Medicant delivery system and method

ABSTRACT

A tracheal tube positioning apparatus is located relative to a patient&#39;s trachea by engaging the patient&#39;s Adam&#39;s apple. Indicia on relatively movable sections of the positioning apparatus provides an indication of the distance between the patient&#39;s mouth and the patient&#39;s larynx. A flexible guide rod is moved through a distance corresponding to the distance between the patient&#39;s mouth and larynx, as determined by the positioning apparatus. A magnet is utilized to attract a leading end portion of the guide rod. A plurality of emitters may be disposed in an array around the patient&#39;s Adam&#39;s apple. Outputs from the emitters are detected by a detector connected with the guide rod and by a detector connected with the tracheal tube. Alternatively, a plurality of detectors may be disposed in an array around the patient&#39;s Adam&#39;s apple to detect the output from an emitter connected with the guide rod and by an emitter connected with the tracheal tube. Expandable elements may be connected with the guide rod and/or tracheal tube to steer movement along an insertion path.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.09/728,553, filed on Dec. 2, 2000, the entire contents of which areincorporated by reference.

FIELD OF THE INVENTION

The present invention relates to a new and improved method and apparatusfor use in tracheal intubination or other medical procedures.

BACKGROUND OF THE INVENTION

Tracheal intubination has previously been utilized to provide anunobstructed air passage to a patient's lungs. Tracheal intubination isfrequently done under emergency circumstances which are not optimal. Ithas previously been recognized that is necessary to have a tracheal tubebend around the patient's epiglottis and move from the patient's pharynxinto the larynx at the upper end of the patient's trachea rather thaninto the patient's esophagus. However, it is difficult for a personinserting the tracheal tube to know where the leading end portion of thetracheal tube is located relative to the patient's larynx.

Various methods and devices for assisting in tracheal intubination aredisclosed in U.S. Pat. Nos. 4,832,020; 4,865,586; 4,913,139; 5,353,787;5,235,970; 5,560,351; and 5,694,929.

SUMMARY OF THE INVENTION

An improved method and apparatus for use in tracheal intubination orother medical procedure may include a positioning apparatus. When thepositioning apparatus is used for tracheal intubination, the positioningapparatus is located relative to a patient's trachea by engaging aportion of the patient's body, such as the Adam's apple. A flexibleguide rod may be moved relative to the positioning apparatus until aleading end portion of the guide rod has moved into the patient'strachea. A tracheal tube is slid along the guide rod into the patient'strachea.

During movement of the guide rod relative to the positioning apparatus,the guide rod may be moved through either a tubular guide member or atracheal tube which extends through the patient's mouth into thepatient's pharynx. Before beginning to move the guide rod, the distancewhich the guide rod is to be moved may advantageously determined. Thismay be done as a function of spacing between locations on thepositioning apparatus. If desired, indicia may be provided on thepositioning apparatus and cooperating indicia may be provided on theguide rod.

A magnet may be utilized to attract a leading end portion of the guiderod. The magnet is disposed outside of the patient's body and may bepositioned adjacent to an anterior side of the trachea. Magneticattraction between the magnet and the leading end portion of the guiderod deflects the guide rod. This steers the leading end portion of theguide rod into the entrance to the patient's trachea. A magnet may beused to steer a member relative to a patient's body tissue duringperformance of operations other than tracheal intubination.

In order to locate the guide rod and/or tracheal tube relative to thepatient's trachea, an image of body tissue adjacent to the leading endportion of the guide rod and/or tracheal tube may be transmitted to alocation outside of the patient's body. Movement of the guide rod and/ortracheal tube into the patient's trachea is interrupted when the imagetransmitted from the leading end portion of the guide rod or trachealtube indicates that the leading end portion of the guide rod or trachealtube has been moved to a desired position relative to the patient'strachea.

It is believed that transmission of an image of body tissue adjacent tothe leading end portion of the tracheal tube may advantageously beperformed when the tracheal tube is utilized without benefit of thepositioning apparatus. However, the transmission of an image of bodytissue adjacent to the leading end portion of the tracheal tube may beperformed when the positioning apparatus is used in association with thetracheal tube. Positioning of the guide rod relative to the patient'strachea may also be facilitated by the transmitting of images of bodytissue adjacent to a leading end portion of the guide rod.

Detectors and emitters may be utilized to detect the position of theleading end portion of the guide rod and/or the tracheal tube relativeto the patient's trachea. When this is done, an emitter, such as amagnet or a light source, may be connected with a leading end portion ofthe guide rod and/or the tracheal tube. One or more detectors may beprovided on the outside of the patient's neck to detect the output fromthe emitter when the guide rod and/or the tracheal tube are in a desiredposition relative to the patient's trachea. Alternatively, a detectormay be connected with the leading end portion of a guide rod and/ortracheal tube and one or more emitters positioned relative to theoutside of the patient's neck. The detector would provide an outputindicating when the guide rod and/or tracheal tube is moved to a desiredposition relative to the patient's trachea.

During movement of the guide rod and/or tracheal tube along thepatient's respiratory system and into the patient's trachea, force maybe applied against the leading end portion of the guide rod and/ortracheal tube to steer the leading end portion of the guide rod and/ortracheal tube. The application of force against the leading end portionof the guide rod and/or tracheal tube may be accomplished by expandingan expandable element connected with the guide rod and/or the trachealtube.

It should be understood that any one of the features of the presentinvention may be used separately or in combination with other featuresof the invention. It's believed that various combinations of thefeatures, other than those disclosed herein, may advantageously beutilized and will be apparent to those skilled in the art from thedescription contained herein. In addition, it should be understood thatfeatures of the present invention may be used for purposes other thantracheal intubination.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the present invention will becomemore apparent upon a consideration of the following description taken inconnection with the accompanying drawings wherein:

FIG. 1 is a fragmentary schematic illustration depicting the use of apositioning apparatus to position a guide rod relative to the mouth andtrachea of a patient;

FIG. 2 a fragmentary schematic illustration depicting the manner inwhich a tracheal tube is moved along the guide rod of FIG. 1 into thetrachea of the patient;

FIG. 3 is a fragmentary schematic illustration, similar to FIG. 1,illustrating the manner in which a laryngoscope may be combined with thepositioning apparatus;

FIG. 4 is a fragmentary schematic illustration depicting the use ofanother embodiment of the positioning apparatus to position a guide rodrelative to the mouth and trachea of a patient;

FIG. 5 is an enlarged schematic fragmentary sectional view of a portionof the apparatus of FIG. 4 and illustrating the relationship between aguide rod and a guide tube;

FIG. 6 is an enlarged schematic fragmentary sectional view of a portionof the apparatus of FIG. 4 and illustrating the relationship between theguide tube, guide rod, and a guide member in the positioning apparatus;

FIG. 7 is a schematic fragmentary sectional view illustrating a mannerin which the positioning apparatus engages a patient's Adam's apple andthe manner in which a magnet is moved along the outside of the neck ofthe patient;

FIG. 8 (on sheet 3 of the drawings) is an enlarged fragmentary schematicillustration of indicia on a portion of the guide rod of FIG. 4;

FIG. 9 is a fragmentary schematic illustration of the guide rod with thepositioning apparatus and guide tube of FIG. 4 removed after positioningof the guide rod relative to the patient's trachea;

FIG. 10 is a fragmentary schematic illustration, generally similar toFIG. 9, illustrating the manner in which a tracheal tube is moved alongthe guide rod into the patient's trachea;

FIG. 11 is a fragmentary schematic illustration, generally similar toFIG. 4, illustrating an embodiment of the apparatus in which thetracheal tube is used to guide movement of the guide rod;

FIG. 12 is a fragmentary schematic illustration, similar to FIG. 1,illustrating an embodiment of the positioning apparatus which transmitsan image of body tissue adjacent to a leading end portion of the guiderod;

FIG. 13 is a fragmentary schematic illustration, generally similar toFIGS. 1 and 12, of an embodiment of the invention in which a detector ona leading end portion of a guide rod detects emitters disposed on theneck of the patient;

FIG. 14 is a fragmentary schematic illustration, depicting the manner inwhich a plurality of emitters are arranged in an array around theAdams's apple of the patient of FIG. 13;

FIG. 15 is a fragmentary schematic illustration, generally similar toFIG. 13, of an embodiment of the invention in which detectors on theneck of the patient detect an emitter on a leading end portion of theguide rod;

FIG. 16 is a fragmentary schematic illustration, generally similar toFIG. 14, illustrating a manner in which a plurality of detectors arepositioned in an array around the Adam's apple on the neck of thepatient of FIG. 15;

FIG. 17 is an enlarged schematic fragmentary sectional view of theleading end portion of a guide rod on which a detector and a pluralityof expandable steering elements are disposed;

FIG. 18 is a plan view, taken generally along the line 18-18 of FIG. 17,further illustrating the relationship of the expandable steeringelements to the leading end portion of the guide rod;

FIG. 19 is a schematic fragmentary sectional view of a leading endportion of a guide rod on which an emitter and a plurality of expandablesteering elements are disposed;

FIG. 20 is an enlarged schematic fragmentary sectional view of a leadingend portion of a tracheal tube and illustrating the manner in which alight source and light conductor are disposed on the tracheal tube tofacilitate visualization of tissue disposed adjacent to the leading endportion of the tracheal tube;

FIG. 21 is an enlarged schematic fragmentary sectional view of a leadingend portion of a tracheal tube and illustrating a plurality of detectorswhich are disposed on the leading end portion of tracheal tube;

FIG. 22 is an enlarged schematic fragmentary sectional view of a leadingend portion of a tracheal tube illustrating the manner in which aplurality of emitters and expandable steering elements are mounted onthe leading end portion of the tracheal tube;

FIG. 23 is a schematic illustration depicting the positioning apparatusof FIGS. 1 and 2;

FIG. 24 is a schematic illustration, generally similar to FIG. 23,illustrating another embodiment of the apparatus of FIGS. 1 and 2;

FIG. 25 is a fragmentary schematic illustration of a portion of apositioning apparatus having another embodiment of the positioningsection;

FIG. 26 is a fragmentary schematic illustration depicting therelationship between the positioning section of FIG. 25 and a patient'sAdam's apple during use of the positioning apparatus;

FIG. 27 is a fragmentary schematic illustration of a portion of apositioning apparatus having another embodiment of the positioningsection; and

FIG. 28 is a fragmentary schematic illustration depicting therelationship between the positioning section of FIG. 27 and a patient'sAdam's apple during use of the positioning apparatus.

DETAILED DESCRIPTION OF THE INVENTION

General Description

The present invention relates to a new and improved method and apparatusfor use in tracheal intubination or other medical procedures. A portionof a patient's head 10 and respiratory system 11 has been illustratedschematically in FIG. 1. The schematicized illustration of the patient'shead 10 and respiratory system 11 includes a mouth 12 which is connectedwith a throat 14 in a neck 16 of the patient.

A pharynx extends downward from a nasal cavity in the head 10 of thepatient. The pharynx is connected with an esophagus 26 and a trachea 28in the neck 16 of the patient. The esophagus 26 extends from the pharynxto the stomach of the patient. The trachea 28 extends from the pharynxto the bronchial tubes and lungs of the patient.

The trachea 28 (FIG. 1) has an upper end portion 30 which is referred toas the larynx. Vocal cords or folds 32 have been indicated schematicallyin FIG. 1 and are disposed in the larynx 30. The vocal cords 32 areadjacent to the Adam's apple 34 of the patient. The Adam's apple 34 is alaryngeal prominence formed by lamina of cartilage in the larynx.

Opening of a passage for air from the patient's mouth to the patient'slungs may require insertion of a flexible tracheal tube 38 (FIG. 2).Movement of the flexible tracheal tube 38 from the patient's mouth 12into the pharynx of the patient is relatively easily accomplished.However, directing the tracheal tube 38 into the patient's trachea 28may present difficulties. This is because the tracheal tube must extendpast the epiglottis into the larynx 30 at the upper end of the trachea28. The tracheal tube 38 must not enter the esophagus 26 rather than thetrachea 28. During movement of the leading end of the tracheal tube 38through the larynx 30, it is desirable to have the tracheal tube nearthe central portion of the laryngeal cavity in order to minimizeirritation of the vocal folds or cords 32 by the tracheal tube.

In accordance with one of the features of the present invention, aflexible guide wire or rod 50 (FIG. 1) is utilized to guide movement ofthe flexible tracheal tube 38 (FIG. 2) into the trachea 28. The flexibleguide rod 50 has a soft generally spherical leading end portion 52. Theleading end portion 52 of the guide rod 50 is formed of a resilientlycompressible material which is readily deflected by engagement with thevocal cords or folds 32 and by engagement with the surface of thetrachea 28. If desired, the leading end portion 52 of the guide rod 50may be coated with a suitable lubricant to facilitate movement of theleading end portion between the vocal cords with minimum of irritation.

In accordance with another of the features of the invention, the guidewire 50 is initially positioned relative to the patient's trachea 28with a positioning apparatus 56 (FIG. 1). The positioning apparatus 56engages the patient's Adam's apple 34 to locate the positioningapparatus relative to the trachea 28 of the patient. In addition, thepositioning apparatus 56 provides a measurement which is a function ofthe distance between the Adam's apple 34 and the mouth 12 of thepatient. This measurement is utilized to determine the distance throughwhich the guide rod 50 is to be moved relative to the positioningapparatus 56 as the guide rod is inserted into the trachea 28.

Positioning Apparatus

The positioning apparatus 56 has been and will be described herein inassociation with tracheal intubination. However, it is contemplated thatthe positioning apparatus 56 will be used in association with many othermedical procedures where accurate positioning of an object relative tobody tissue is desired. The positioning apparatus may be used inassociation with endoscopic, arthroscopic or fiber optic surgicalprocedures. It is believed that the positioning apparatus 56 will beused in conjunction with medical procedures where it is necessary toposition an object at a location in a patient's body where there is onlylimited access.

The positioning apparatus 56 positions the guide rod 50 relative to thepatient's trachea 28 during insertion of the guide rod into thepatient's trachea. In addition, the positioning apparatus 56 provides anindication of the distance which the guide rod is to be moved into thepatient's trachea. By using the positioning apparatus 56, a personmoving the guide rod 50 into the patient's trachea 28 can know where theleading end portion 52 of the guide rod is located relative to thetrachea.

The flexible guide rod 50 may be formed of either polymeric material ormetal. The illustrated polymeric guide rod 50 has a relatively smalldiameter and is readily deflected. The guide rod 50 has a circular crosssectional configuration.

The guide rod 50 is axially movable relative to the positioningapparatus 56 under the influence of force manually applied to theportion of the guide rod disposed to the left (as viewed in FIG. 1) ofthe positioning apparatus 56. This force results in axial movement ofthe guide rod 50 relative to the positioning apparatus 56. In addition,the leading end 52 of the guide rod 50 may deflect body tissue to cleara passage for the guide rod 50.

As the guide rod 50 is moved axially relative to the positioningapparatus 56, the guide rod may be resiliently deflected by engagementwith the body tissue of the patient. As the guide rod 50 is manuallypushed toward the right (as viewed in FIG. 1), the leading end 52 of theguide rod moves toward the larynx 30.

The positioning apparatus 56 is used to locate the leading end portion52 of the guide rod 50 as the guide rod moves toward the larynx 30. Thepositioning apparatus 56 includes a base section 78 and an arcuate uppersection 80 (FIG. 1). The base section 78 engages the patient's Adam'sapple 34 to locate the positioning apparatus 56 relative to thepatient's trachea 28. The upper section 80 of the positioning apparatus56 guides movement of the guide rod 50 during insertion of the guide rodinto the patient's trachea 28.

The base section 78 and upper section 80 of the positioning apparatus 56cooperate to provide a measurement of the distance between the patient'smouth 12 and the patient's Adam's apple 34. This distance will vary frompatient to patient depending upon the size of the patient, the specificconfiguration of the head 10 of the patient, and other factors. Thedistance which the guide rod 50 must be moved axially into the patient'slarynx 30 will vary as a function of variations in the distance betweenthe patient's mouth 12 and the patient's Adam's apple 34. This isbecause the patient's Adam's apple 34 is located adjacent to theentrance to the trachea 28.

The positioning apparatus 56 can be used to position many differentobjects at desired locations in a patient's body. For example, the guiderod 50 or a similar member could be inserted into a patient's stomach orcolon. The base section 78 of the positioning apparatus would bepositioned in engagement with an exterior surface on the patient's bodyat a location where the leading end portion 52 of the guide rod 50 is tobe moved. The upper section 80 of the positioning apparatus 56 wouldcooperate with the base section 78 and guide rod 50 to provide a clearindication of the location of the leading end portion 52 of the guiderod 50 relative to the patient's body tissue, for example, the patient'sstomach or colon.

The base section 78 (FIG. 1) of the positioning apparatus 56 includes atubular cylindrical body section 86. The base section 78 also includes apositioning section 96 which engages the patient's Adam's apple 34 andis supported by the body section 86. The positioning section 96 engagesthe patient's Adam's apple 34. Although the illustrated positioningsection 96 (FIG. 1) engages only a single location on the patient's neck16, the positioning section could be constructed so as to engage aplurality of locations on the patient's neck. For example, it may bepreferred to use a positioning section 96 having two positioning fingersdisposed on laterally opposite sides of the Adam's apple 34.

It is contemplated that the positioning section 96 could have manydifferent constructions. It is believed that it may be particularlyadvantageous to utilize a positioning section 96 having the constructionillustrated in FIGS. 25 and 26 herein. Alternatively, the positioningsection 96 may have the construction illustrated in FIGS. 27 and 28 orFIGS. 4 and 7 herein if desired.

Force may be manually applied against the positioning section 96 tostraighten the trachea 28 of the patient. Thus, the patient's trachea 28may have a slight anterior bend when the patient's head 10 is in theposition illustrated in FIG. 1. This slight bend can be eliminated bythe manual application of minimal force to the positioning section 96.This force presses the positioning section 96 against the patient'sneck.

Although it is preferred to use the patient's Adam's apple 34 to locatethe positioning apparatus 56 relative to the patient's trachea 28, adifferent portion of the patient's body could be used to locate thepositioning apparatus relative to the patient's trachea. For example,the patient's shoulders could be used. Alternatively, bones in thepatient's neck 16 could be used to locate the positioning apparatus 56relative to the patient's trachea 28. However, it is believed that itwill be preferred to use the patient's Adam's apple 34 to locate thepositioning apparatus 56 due to the close proximity of the patient'sAdam's apple to the upper end of the patient's trachea 28.

The arcuate upper section 80 of the positioning apparatus 56 includes anarcuate member 108 which is slidably connected with the body section 86at a connection 110. The connection 110 is movable axially along thecylindrical body section 86. The body section 86 is movable transverselyto the arcuate member 108, in the manner indicated by the arrows 112 inFIG. 1. Suitable indicia, indicated by lines in FIG. 1, may be providedon the arcuate member 108 to indicate the position of the connection 110relative to the arcuate member.

The connection 110 may include a plurality of set screws (not shown)having manually engagable flanges or arms. One of the set screws may betightened to prevent movement between the body section 86 and theconnection 110. Another set screw may be tightened to prevent movementbetween the arcuate member 108 and the connection 110.

When the connection 110 has been moved to a desired location along thebody section 86, a set screw in the connection is tightened to hold thearcuate member 108 against axial movement along to the cylindrical bodysection 86. The arcuate member 108 is then moved transversely to thebody section 86, that is, in the direction of the arrows 112, toposition a guide section 114 in alignment with the patient's mouth 12and trachea 28. When the tubular guide section 114 has been aligned withthe patient's trachea 28, another set screw in the connection 110 istightened to hold the arcuate member 108 against transverse movementrelative to the body section 86.

The guide rod 50 extends through a cylindrical passage in the guidesection 114. Therefore, transverse movement of the arcuate member 108relative to the body section 86, that is, in the direction indicated bythe arrows 112 positions the guide rod 50 in alignment with thepatient's mouth 12. The guide rod 50 is axially movable relative to theguide section 114 into the patient's mouth 12 and trachea 28.

In the illustrated embodiment of the invention, the distance between thepatient's Adam's apple 34 and the arcuate member 108 is indicated byindicia 124 (FIG. 1). The indicia 124 is disposed on the cylindricalbody section 86 of the positioning apparatus 56. The position of theconnection 110 relative to the indicia 124 indicates the distance whichthe arcuate member is spaced from the positioning section 96. Thedistance which the connection 110 is spaced from the positioning section96 is a function of the distance between the patient's Adam's apple 34and the entrance to the patient's mouth 12.

In the illustrated embodiment of the invention, the indicia 124 isformed by a plurality of colored bands 130. Each of the bands 130 has adifferent color from the other bands. Each of the bands 130 has the sameaxial extent. However, the bands could have different axial extents ifdesired. Rather than using the colored bands 130 as the indicia 124,numerical indicia could be provided. However, it is believed that it maybe easier to read the different colored bands 130 than to read numericalindicia.

Colored bands 142 are provided on the guide rod 50. The colored bands142 have different colors which correspond to the colors of the bands130 on the cylindrical body section 86 of the positioning apparatus 56.The colored bands 142 on the guide rod 50 are spaced from the endportion 52 of the guide rod by the same distance which correspondinglycolored bands 130 on the body section 86 are spaced from the center ofthe Adam's apple 34.

The bands 142 on the guide rod 50 cooperate with an end portion 156(FIG. 1) of the guide section 114 to indicate when the leading endportion 52 of the guide rod is in a desired position relative to thepatient's trachea 28. Thus, assuming that a red colored band 130 on thecylindrical body section 86 of the positioning apparatus 56 is alignedwith the connection 110, the red band on the guide rod 50 will be movedto a position in which it is adjacent to the guide section 114. When theguide rod 50 has been moved to a position in which the red band isadjacent to the guide section 114, the leading end portion 52 of theguide rod will have moved through a desired distance into the patient'strachea 28 and will be aligned with the patient's Adam's apple 34.

When the positioning apparatus 56 is to be associated with a differentportion of a patient's body, the indicia 124 would be revised tocorrespond to the distance which the guide rod 50 is to be movedrelative to the arcuate member 108 to bring the leading end portion 52of the guide rod into alignment with the positioning section 96 or to aposition spaced a desired distance from the positioning section. It iscontemplated that the positioning apparatus 56 maybe used duringendoscopic, arthroscopic, or fiber optic surgery at many locations in apatient's body, for example during surgery on joints in the patient'sbody.

The positioning apparatus 56 may be used in association with thedelivery of medicants to relatively inaccessible locations in apatient's body. For example, a medicant could be connected with theleading end portion 52 of the guide rod 50 and released when the indicia124 indicated that the medicant has been moved to a desired positionrelative to the positioning section 96. The medicant may be released byactivating a holder, disposed at the leading end portion 52 of the guiderod. A Bowden cable or other actuator may extend through the guide rodto the medicant holder to operate the medicant holder from a closedcondition to an open condition to release the medicant.

Tracheal Intubination

Once the guide rod 50 has been moved through a desired distance into thepatient's trachea 28, the positioning apparatus 56 is separated from theguide rod 50 while the guide rod remains stationary relative to thepatient's trachea. Thus, once the indicia 142 on the guide rod 50indicates that the leading end portion 52 of the guide rod has beenmoved through a desired distance into the patient's trachea 28, axialmovement of the guide rod 50 is interrupted. At this time, one of thecolored bands 142 on the guide rod 50 corresponding to the one of thecolored bands 130 aligned with the connection 110, is aligned with theend surface 156 on the guide section 114.

The guide section 114 is then slid axially outward, that is toward theleft as viewed in FIG. 1, along the guide rod 50. During this slidingmovement of the guide section 114 along the guide rod 50, the guide rodis manually held against movement relative to the patient's mouth 12 andtrachea 28. The upper section 80 and base section 78 are separated fromthe patient during movement of the guide section 114 along the guide rod50. As this occurs, the guide rod 50 is stationary relative to thepatient.

Once the upper section 80 has been separated from the guide rod 50, thetracheal tube 38 (FIG. 2) is slid along the guide rod 50 into thepatient's trachea 28. Thus, the end of the guide rod 50 remote from thepatient's mouth 12 and trachea 28 is inserted into the tracheal tube 38.As this is done, the guide rod 50 is manually held against movementrelative to the patient's mouth 12 and trachea 28. The tracheal tube 38is then moved axially along the guide rod 50 while the leading endportion 52 of the guide rod remains stationary in the patient's trachea.

As the tracheal tube 38 is moved axially along the guide rod 50, theguide rod directs the leading end portion of the tracheal tube into thepatient's larynx 30 and past the vocal cords 32. The leading end of thetracheal tube 38 is centered in the space between the vocal cords andthe entrance to the patient's trachea by the guide rod 50. Thisminimizes irritation of the patient's vocal cords 32. The tracheal tube38 is moved along the guide rod 50 at least until the leading end of thetracheal tube engages the leading end portion 52 of the guide rod 50.

It is contemplated that it may be desired to move the tracheal tube 38further into the patient's trachea 28 than the distance which the guiderod 50 is moved into the patient's trachea. If this is the case, thetracheal tube 38 is pushed axially along the guide rod 50 past theleading end portion 52 of the guide rod. As this occurs, the leading endportion 52 of the guide rod 50 is compressed slightly and enters thetracheal tube 38.

Once the tracheal tube 38 has been moved to a desired depth into thepatient's trachea 28, the guide rod 50 is removed from the tracheal tube(FIG. 7). The tracheal tube 38 then provides a passage for theconduction air, other gases, and/or medication to the patient's lungs.

Laryngoscope

This contemplated that a laryngoscope 170 (FIG. 3) maybe connected withthe connection 110 which interconnects the body section 86 and arcuateupper section 80 of the positioning apparatus 56. The laryngoscope 170and body section 86 are moveable relative to each other to enable thelaryngoscope to be positioned in the patient's mouth 12. As thelaryngoscope 170 is inserted into the patient's mouth 12, thelaryngoscope engages the patient's tongue. The laryngoscope then holdsthe patients tongue in a desired position in the mouth 12 of thepatient.

The laryngoscope 170 is then inserted further into the patient's mouth12 to expose progressively deeper structures within the oropharynx. Thelaryngoscope 170 could be advanced to facilitate visualization of theglottic opening in a known manner. Although the laryngoscope may beprovided as part of the positioning apparatus 56, in the mannerillustrated in FIG. 3, it is contemplated that the laryngoscope 170could be separate from the positioning apparatus if desired. Regardlessof whether the laryngoscope 170 is formed as part of the positioningapparatus 56 or separate from the positioning apparatus, thelaryngoscope is utilized in a known manner in management of thepatient's tongue and airway.

Second Embodiment

A second embodiment of the invention is illustrated in FIGS. 4 through10. Since the embodiment of the invention illustrated in FIGS. 4-10 isgenerally similar to embodiment of the invention illustrated in FIGS.1-3, similar terminology will be utilized to refer to similarcomponents.

A portion of a patient's head 210 has been illustrated schematically inFIG. 4. The patient's head includes a mouth 212 which is connected witha throat 214 and a neck 216 of the patient. Although the patient's head210 has been schematically illustrated in an upright orientation in FIG.4, it should be understood that the patient's head could be in adifferent orientation if desired. For example, the patient's head 210could be in the orientation illustrated in FIGS. 1 and 2 for thepatient's head 10.

A pharynx 220 extends downward from a nasal cavity 222 in the head 210of the patient. The pharynx 220 is connected with an esophagus 226 and atrachea 228 in the neck 216 of the patient. The esophagus 226 extendsfrom the pharynx 220 to the stomach of the patient. The trachea 228extends from the pharynx to the bronchial tubes and lungs of thepatient.

The trachea 228 (FIG. 4) has an upper end portion 230 which is referredto as the larynx. Vocal cords or folds 232 have been indicatedschematically in FIG. 3 and are disposed in the larynx 230. The vocalcords 232 are adjacent to the Adam's apple 234 of the patient. TheAdam's apple 234 is a laryngeal prominence formed by lamina of cartilagein the larynx.

Opening of a passage for air from the patient's mouth to the patient'slungs may require insertion of a flexible tracheal tube 238 (FIG. 10).Movement of the flexible tracheal tube 238 from the patient's mouth 212into the pharynx 220 of the patient is relatively easily accomplished.However, directing the tracheal tube 238 into the patient's trachea 228may present difficulties. This is because an anterior bend 240 must beformed in the tracheal tube 238. The anterior bend 240 extends aroundthe epiglottis 242 into the larynx 230 at the upper end of the trachea228. The anterior bend 240 can be minimized by placing the patient inthe orientation illustrated in FIGS. 1 and 2.

During movement of the leading end of the tracheal tube 238 through thelarynx 230, it is desirable to have the tracheal tube near the centralportion of the laryngeal cavity in order to minimize irritation of thevocal folds or cords 232 by the tracheal tube. In accordance with afeature of the present invention, a flexible guide wire or rod 250(FIGS. 4 and 9) is utilized to guide movement of the flexible trachealtube 238 (FIGS. 9 and 10) into the trachea 228. The flexible guide rod250 (FIG. 9) has a soft generally spherical leading end portion 252. Theleading end portion 252 of the guide rod 250 is formed of a resilientlycompressible material which is readily deflected by engagement with thevocal cords or folds 232 and by engagement with the surface of thetrachea 228. If desired, the leading end portion 252 of the guide rod250 may be coated with a suitable lubricant to facilitate movement ofthe leading end portion between the vocal cords with minimum ofirritation.

In accordance with another feature of the invention, the guide wire 250is initially positioned relative to the patient's trachea 228 with apositioning apparatus 256 (FIG. 4). The positioning apparatus 256engages the patient's Adam's apple 234 to locate the positioningapparatus relative to the trachea 228 of the patient. In addition, thepositioning apparatus 256 provides a measurement which is a function ofthe distance between the Adam's apple 234 and the mouth 212 of thepatient. This measurement is utilized to determine the distance throughwhich the guide rod 250 is to be moved relative to the positioningapparatus 256 as the guide rod is inserted into the trachea 228.

In accordance with still another feature of the present invention, amagnet 260 (FIG. 4) is utilized to attract the leading end portion 252of the guide rod 250 and to steer the leading end portion of the guiderod into the patient's trachea 228. The magnet 260 is a permanent magnetformed of a strongly magnetizable material such as cobalt and neodymium.Of course, other known magnetizable materials having high saturationmagnetization values, such as cerium, praseodymium, and/or samarium withcobalt and/or other materials, could be used. Alternatively, the magnet260 may be an electromagnet.

To enable the leading end portion 252 of the guide rod 250 to beattracted by a magnetic field emanating from the magnet 260, the leadingend portion 252 of the guide rod contains ferrite particles. The ferriteparticles may or may not be magnetized. Or course, other knownmagnetizable or magnetic particles could be utilized. When a magnet ispositioned on the leading end portion 252 of the guide rod 250, thepolarity of the leading end of the magnet on the guide rod is oppositefrom the polarity of the magnet 260.

As the guide rod 250 is moved downward (as viewed in FIG. 4) along thepatient's pharynx toward the larynx 230, the leading end portion 252 ofthe guide rod enters the field of the magnet 260. The field of themagnet 260 has sufficient strength to cause the guide rod 250 to deflectslightly toward the right (as viewed in FIG. 4). As this occurs, theleading end portion 252 of the guide rod moves into the larynx 230 at alocation adjacent to the center of the larynx. This enables the leadingend portion 252 of the guide rod 250 to move between the vocal cords orfolds 232 with a minimum of irritation to the vocal cords. Although themagnet 260 is described herein as steering the leading end portion 252of the guide rod 250 into the trachea, it is contemplated that themagnet could be utilized to steer members at many different locations ina patient's body.

The magnet 260 may be an electromagnet. If the magnet 260 is anelectromagnet, the magnet may be turned on and off, that is, energizedand de-energized during steering of the leading end portion 252 of theguide 250. If desired, the leading end portion 252 of the guide rod 250could also be formed by an electromagnet. If this was done, conductorsfor connecting the leading end portion 252 of the guide 250 would extendalong the inside of the guide rod. By reversing the direction of currentflow to either the electromagnet forming the magnet 260 or theelectromagnet forming the leading end portion 252 of the guide rod 250,the two electromagnets could be made to sequentially attract and repeleach other.

Steering of the leading end portion 252 of the guide rod 250 with themagnet 360 is facilitated by moving the magnet along the patient's neck216, in the manner indicated schematically in FIG. 7. The magnet 360 maybe moved up and down along the patient's neck. The magnet 360 may alsobe moved sidewards relative to the patient's neck. By moving the magnet360 relative to the patient's neck, a magnetic field emanating from themagnet is effective to pull the leading end portion 252 of the guide rod250 in the desired direction.

Although the use of the magnet 260 has been disclosed herein inassociation with the embodiment of the invention illustrated in FIGS.4-10, it is contemplated that the magnet 260 could be used inassociation with other embodiments of the invention. For example, themagnet 260 could be used with the embodiment of the inventionillustrated in FIGS. 1 and 2.

The magnet 260 may be used to steer devices other than the guide rod250. When the positioning apparatus 56 (FIG. 1) is to be associated witha portion of a patient's body other than the trachea, the magnet 260(FIG. 4) could be used to steer any one of many different devices to adesired location in the patient's body. A positioning apparatus, similarto the positioning apparatus 56 of FIG. 1 or the positioning apparatus256 of FIG. 4, and a magnet, similar to the magnet 260 may be usedduring endoscopic, arthroscopic, or fiber optic surgery at manydifferent locations in a patient's body. Thus, the magnet 260 may beused to steer a guide rod being positioned relative to a joint by apositioning apparatus, similar to the positioning apparatus 56 of FIG. 1and the positioning apparatus 256 of FIG. 4, during surgery at thejoint. The magnet 260 may also be used to position medicants at desiredlocations in the patient's body. Although it is believed that the magnet260 will be advantageously used in association with a positioningapparatus similar to the positioning apparatus 56 of FIG. 1 or the otherpositioning apparatus 256 of FIG. 4, the magnet may be used insituations where the positioning apparatus is not required.

Positioning Apparatus of FIGS. 4-10

The positioning apparatus 256 (FIG. 4) positions the guide rod 250relative to the patient's trachea 228 during insertion of the guide rodinto the patient's trachea. In addition, the positioning apparatus 256provides an indication of the distance which the guide rod is to bemoved into the patient's trachea. By using the positioning apparatus256, a person moving the guide rod 250 into the patient's trachea 228can know where the leading end portion 252 of the guide rod is locatedrelative to the trachea.

During movement of the guide rod 250 into the patient's trachea, theguide rod is moved axially through a flexible, generally cylindrical,guide tube 264 (FIG. 5). The guide tube 264 is formed of a resilientpolymeric material. The guide tube 264 has a main section 266 and aleading end section 268. The leading end section 268 has a side wall 270which is thinner than a side wall 272 of the main section 266. The sidewall 270 is integrally molded as one piece with the thicker side wall272. A generally cylindrical passage 274 (FIG. 5) extends axiallythrough the guide tube 264.

The thin walled leading end section 268 of the guide tube 264 is moldedso as to naturally assume the arcuate configuration illustrated in FIGS.4 and 5. This enables the end section 268 of the guide tube 264 to bepositioned in the patient's pharynx 220 (FIG. 4) with the end sectionforming a bend which extends around the upper end portion of thepatient's epiglottis 242. Since the leading end section 268 has arelatively thin side wall (FIG. 5), the end section can be easilydeflected as it is moved into position in the patient's pharynx 220. Thethicker side wall 272 of the main section 266 of the guide tube 264 iseffective to support the leading end section 268 in the patient'spharynx 220 and to depress a tongue 76 in the mouth 212 of the patient(FIG. 1).

The guide rod 250 may be formed of either polymeric material or metal.The illustrated polymeric guide rod 250 has a relatively small diameterand is readily deflected. The guide rod 250 has a circular crosssectional configuration.

The guide rod 250 extends axially through the guide tube 264 (FIG. 4).The guide rod 250 is axially movable relative to the guide tube 264under the influence of force manually applied to the portion of theguide rod disposed to the right (as viewed in FIG. 4) of the positioningapparatus 256. This force results in axial movement of the guide rod 250along the guide tube 264.

As the guide rod 250 is axially moved along the guide tube 264, thearcuate leading end section 268 of the guide tube 264 resilientlydeflects the guide rod 250 to form the arcuate bend illustrated in FIG.4. As the guide rod 250 is manually pushed toward the left (as viewed inFIG. 4), the leading end 52 of the guide rod moves downward (as viewedin FIG. 4) toward the larynx 230. As the leading end 252 of the guiderod 250 moves downward (as viewed in FIG. 4), tissues which may tend toblock movement of the guide rod are pushed aside by the leading end ofthe guide rod. This clears a passage for the guide rod 250.

The positioning apparatus 256 is used to locate the leading end portion252 of the guide rod 250 as the guide rod moves along the guide tube264. The positioning apparatus 256 includes a base section 278 and anupper section 280 (FIG. 4). The base section 278 engages the patient'sAdam's apple 234 to locate the positioning apparatus 256 relative to thepatient's trachea 228. The upper section 280 of the positioningapparatus 256 holds the guide tube 264 which guides movement of theguide rod 250 during insertion of the guide rod into the patient'strachea 228.

The base section 278 and upper section 280 of the positioning apparatus256 cooperate to provide a measurement of the distance between thepatient's mouth 212 and the patient's Adam's apple 234. This distancewill vary from patient to patient depending upon the size of thepatient, the specific configuration of the head 210 of the patient, andother factors. The distance which the guide rod 250 must be movedaxially relative to the guide tube 264 to move the leading end portion252 of the guide rod into the patient's larynx 230 will vary as afunction of variations in the distance between the patient's mouth 212and the patient's Adam's apple 234. This is because the patient's Adam'sapple 234 is located adjacent to the entrance to the trachea 228.

The base section 278 of the positioning apparatus 256 includes anupright tubular cylindrical body section 286. The body section 286 has acylindrical chamber 288. The cylindrical upper section 280 of thepositioning apparatus 256 is telescopically received in the chamber 288.

In addition, the base section 278 includes an end section 290. The endsection 290 extends perpendicular to the body section 286. The endsection 290 has a cylindrical central passage 292 which extendsperpendicular to and intersects the central axis of the chamber 288. Thebody section 286 and the end section 290 are integrally molded as onepiece of polymeric material.

The base section 278 also includes a positioning section 296 whichengages the patient's Adam's apple 234 and is supported by the endsection 290. The positioning section 296 includes a cylindrical supportrod 298 which extends through the passage 292 and is connected with alocating portion 302 which engages the patient's Adam's apple 234. Thelocating portion 302 includes a generally hemispherical dome 304 and aresilient annular collar 306 which is connected to the rim of the dome304. The collar 306 extends around the Adam's apple 234 and engagesupper and lower sides and left and right sides of the Adam's apple tocenter the dome 304 on the Adam's apple.

If desired, the locating portion 302 could be constructed to engage onlytwo sides of the Adam's apple 234. For example, the left and right sidesof the Adam's apple 234. It is believed that it may be desired to formthe locating portion 302 with the construction illustrated in FIGS. 25and 26 herein. Alternatively, the locating portion 302 could beconstructed so as to engage only the central portion of the Adam's apple234.

However, it is believed that it may be desired to form the locatingportion 302 so that it extends around the Adam's apple 234 so as tolocate the positioning section 296 relative to the Adam's apple. Forcemay be manually applied against the positioning section 296 to minimizethe anterior bend 240 (FIG. 10) which must be formed in the trachealtube 238. The end section 290 is axially slidable along the support rod298 so that the body section 286 is disposed adjacent to the chin 310 ofthe patient.

Although it is preferred to use the patient's Adam's apple 234 to locatethe positioning apparatus 256 relative to the patient's trachea 228, adifferent portion of the patient's body could be used to locate thepositioning apparatus relative to the patient's trachea. For example,the patient's shoulders could be used. Alternatively, bones in thepatient's neck 216 could be used to locate the positioning apparatus 256relative to the patient's trachea 228. However, it is believed that itwill be preferred to use the patient's Adam's apple 234 to locate thepositioning apparatus 256 due to the close proximity of the patient'sAdam's apple to the upper end of the patient's trachea 228.

The upper section 280 of the positioning apparatus 256 includes acylindrical rod portion 314 which is telescopically received in the bodysection 286 of the positioning apparatus. An upper end section 316 has acylindrical passage 318 through which the guide tube 264 extends. Thepassage 318 has a longitudinal central axis which extends parallel tothe longitudinal central axis of the passage 292 and to the longitudinalcentral axis of the support rod 298. The guide tube 264 is slidable inthe passage 318.

The guide tube 264 extends from the passage 318 into the patient's mouth212. Thus, the passage 318 in the upper section 280 of the positioningapparatus 256 is axially aligned with the patient's mouth 212.Similarly, the passage 292 (FIG. 4) in the end section 290 of the basesection 278 of the positioning apparatus 256 is axially aligned with thepatient's Adam's apple 234. Therefore, the positioning apparatus 256 canbe utilized to measure the distance between the Adam's apple 234 and thepatient's mouth 212.

The entrance through which the guide rod 250 must pass into thepatient's trachea 228 is adjacent to the Adam's apple 234. Therefore,the distance through which the leading end portion 252 of the guide rod250 must be moved relative to the guide tube 264 (FIG. 4) to enter thepatient's trachea 228, is a function of the distance between thepatient's Adam's apple 234 and the patient's mouth 212. The positioningapparatus 256 measures the distance between the patient's Adam's apple234 and the patient's mouth by determining the position of the basesection 278 and upper section 280 of the positioning apparatus relativeto each other.

In the illustrated embodiment of the invention, the distance between thepatient's Adam's apple 234 and the patient's mouth 212 is indicated byindicia 324 (FIG. 6). The indicia 324 is disposed on the cylindrical rodportion 314 of the upper section 280 of the positioning apparatus 256.The rod portion 314 is telescopically received in the cylindricalchamber 288 in the body section 286 of the positioning apparatus 256.

The position of an annular upper end surface 328 on (FIG. 6) the bodysection 286 relative to the indicia 324 indicates the distance which therod portion 314 is extended from the body section 286. The distancewhich the rod portion 314 is extended from the body section 286 is afunction of the distance between the patient's Adam's apple 234 and theentrance to the patient's mouth 212.

In the illustrated embodiment of the invention, the indicia 324 isformed by a plurality of colored bands 330, 332, 334, 336, 338 and 340(FIG. 6). Each of the bands 330-340 has a different color from the otherbands. It should be understood that a lesser or greater number ofcolored bands 330-340 could be provided if desired. It should also beunderstood that although the bands 330-340 have the same axial extent,the bands could have different axial extents if desired. Rather thanusing the colored bands 330-340 as the indicia 324, numerical indiciacould be provided. However, it is believed that it may be easier to readthe different colored bands 330-340 than to read numerical indicia.

Bands 342, 344, 346, 348, and 350 (FIG. 8) are provided on the guide rod250. The colored bands 342-350 have different colors which correspond tothe colors of the bands 132-140 on the rod portion 314 (FIG. 6) of thepositioning apparatus 256. It should be understood that although onlythe bands 342-350 having colors corresponding to the colors of the bands132-140 are illustrated, an additional band having a color correspondingto the color of the band 330 in FIG. 6 is provided on the guide rod 250.

The bands 342-350 (FIG. 8) on the guide rod 250 cooperate with anannular end surface 356 (FIG. 4) on the guide tube 264 to indicate whenthe leading end portion 252 of the guide rod is in a desired positionrelative to the patient's trachea 228. Thus, assuming that the coloredband 334 on the rod portion 314 of the positioning apparatus 256 isaligned with the end surface 328 on the body section 286 (as illustratedin FIG. 6), the band 344 (FIG. 8) on the guide rod 250 will be moved toa position in which it is partially covered by the guide tube 264 andprojects outward from the end surface 356 (FIG. 4) for a distancecorresponding to the distance which the band 334 projects outward fromthe end surface 328 on the body section 286 (FIG. 5). The band 344 has acolor which is the same as the color of the band 334. When the guide rod250 has been moved to a position in which the band 344 is partiallyenclosed by the guide tube 264, the leading end portion 252 of the guiderod will have moved through a desired distance into the patient'strachea 228, for example, a distance of approximately ten centimeters.

The bands 342-350 (FIG. 8) on the guide rod 250 are spaced apredetermined distance from the end surface 356 (FIG. 4) on the guidetube 264 when the leading end portion 252 of the guide rod is disposedin abutting engagement with the leading end section 268 of the guidetube 264. During movement of the indicia on the guide rod 250 from aposition spaced from the end surface 356 of the guide tube 264 to aposition in which the leading band on the guide rod 150 is adjacent tothe end surface 356, the leading end portion 252 of the guide rod 250will have moved from the pharynx 220 of the patient and into the larynx230 past the vocal cords 232.

As the guide rod 250 continues to be manually pushed into the guide tube264, the leading end portion 252 of the guide rod advances downward (asviewed in FIG. 4) in the trachea 228 of the patient. Movement of theguide rod 250 into the trachea 228 of the patient is interrupted whenthe band 344 having a color corresponding to the color of the band 334(FIG. 6) has been partially covered by the guide tube 264.

The magnet 260 is utilized to steer the guide rod 250 during movement ofthe leading end portion 252 of the guide rod from the patient's mouth212 into the patient's trachea 228. As the leading end portion 252 ofthe guide rod 250 is moved downward along the inside of the patient'sneck, the magnet 360 is moved downward along the outside of thepatient's neck. The magnetic field provided by the magnet 360 iseffective to pull the leading end portion 252 downward as the magnetmoves downward. Eventually, the leading end portion 252 of the guide rod250 and magnet 260 will move downward from the entrance to the trachea228 through a desired distance, for example a distance of approximatelyten centimeters. Of course, the leading end portion 252 of the guide rod250 could be moved through a different distance into the trachea 228 ifdesired.

It is contemplated that the distance between the patient's Adam's apple234 and the entrance to the patient's mouth 212 will vary from patientto patient. However, the distance which the leading end portion 252 ofthe guide rod 250 is moved into the patient's trachea 228 will remainconstant at a desired distance, for example, ten centimeters. This isbecause as the distance measured by the positioning apparatus 256increases, the distance which the guide rod 250 is moved relative to theguide tube 264 increases. Conversely, as the distance which is measuredby the positioning apparatus 256 decreases, the distance which the guiderod 250 is moved relative to the guide tube 264 decreases. The distancewhich is measured by the positioning apparatus 256 varies as a functionof the distance between the mouth 212 and larynx 230 of the patient.

Tracheal Intubination

Once the guide rod 250 has been moved through a desired distance intothe patient's trachea 228, the guide tube 264 and positioning apparatus256 are separated from the guide rod 250 while the guide rod remainsstationary relative to the patient's trachea. Thus, once the indicia onthe guide rod 250 indicates that the leading end portion 252 of theguide rod has been moved through a desired distance into the patient'strachea 228, axial movement of the guide rod 250 is interrupted. At thistime, one of the colored bands 342-350 on the guide rod 250corresponding to the one of the colored bands 330-340 aligned with theend surface 328 (FIG. 4) on the body section 286 of the positioningapparatus is aligned with the end surface 356 (FIG. 4) on the guide tube264.

The guide tube 264 is then slid axially outward, that is toward theright as viewed in FIG. 4, along the guide rod 250. During this slidingmovement of the guide tube 264 along the guide rod 250, the guide rod ismanually held against movement relative to the patient's mouth 212 andtrachea 228. The positioning apparatus 256 is moved away from thepatient along with the guide tube 264.

Once the guide tube 264 has been separated from the guide rod 250 (FIG.9), the tracheal tube 238 is slid along the guide rod 250 into thepatient's trachea 228. Thus, the end of the guide rod 250 remote fromthe patient's mouth 212 and trachea 228 is inserted into the trachealtube 238. As this is done, the guide rod 250 is manually held againstmovement relative to the patient's mouth 212 and trachea 228. Thetracheal tube 238 is then moved axially along the guide rod 250 whilethe leading end portion 252 of the guide rod remains stationary in thepatient's trachea. If desired, the magnet 260 may be utilized to attractthe leading end portion 252 of the guide rod 250, in the mannerillustrated in FIG. 9, to facilitate maintaining of the leading endportion of the guide rod stationary in the patient's trachea 228.

As the tracheal tube 238 is moved axially along the guide rod 250, theguide rod directs the leading end portion of the tracheal tube along abend 360 (FIG. 9) formed in the guide rod. After the leading end portionof the tracheal tube 238 has moved around the bend 360, the leading endportion of the tracheal tube enters the patient's larynx and moves pastthe vocal cords 232. The leading end of the tracheal tube 238 iscentered in the space between the vocal cords and the entrance to thepatient's trachea by the guide rod 250. This minimizes irritation of thepatient's vocal cords 232. The tracheal tube 238 is moved along theguide rod 250 at least until the leading end of the tracheal tubeengages the leading end portion 252 of the guide rod 250.

It is contemplated that it may be desired to move the tracheal tube 238further into the patient's trachea than the distance which the guide rod250 is moved into the patient's trachea. If this is the case, thetracheal tube 238 is pushed axially along the guide rod 250 past theleading end portion 252 of the guide rod. As this occurs, the leadingend portion 252 of the guide rod 250 is compressed slightly and entersthe tracheal tube 238.

Once the tracheal tube 238 has been moved to a desired depth into thepatient's trachea 228, the guide rod 250 is removed from the trachealtube (FIG. 10). The tracheal tube 238 then provides a passage for theconduction air, other gases, and/or medication to the patient's lungs.

Method of Utilization

When the tracheal tube 238 is to be inserted into a patient's trachea228, the guide rod 250 is first positioned relative to the guide tube264 at a location spaced from the patient. At this time, the leading endportion 252 of the guide rod 250 is disposed in abutting engagement withthe leading end portion 268 of the guide tube 264. The upper section 280of the positioning apparatus 256 is loosely positioned on the guide tube264. The lower or base section 278 of the positioning apparatus 256 isseparate and spaced from the upper section 280 of the positioningapparatus. A suitable lubricant may be applied to the leading endportion 252 of the guide rod 250 and to the leading end portion 268 ofthe guide tube 264.

The guide tube 264 is then inserted into the patient's mouth 212. As theguide tube 264 is inserted into the patient's mouth, the leading endportion 268 of the guide tube 264 and the leading end portion 252 of theguide rod 250 move from the patient's mouth into the pharynx 220 of thepatient. As the leading end portion 268 of the guide tube 264 moves intothe pharynx 220 of the patient, the natural resilience of the materialof the guide tube causes the guide tube to spring back to its initial orfree configuration illustrated in FIGS. 3 and 4.

As the guide tube 264 and guide rod 250 are manually moved together intothe patient's mouth 212, the guide tube bends itself around the upper(as viewed in FIG. 3) portion of the patient's epiglottis 242. Thisresults in the leading end portion 252 of the guide rod 250 beingpointed downward (as viewed in FIG. 3) toward the lower end portion ofthe patient's pharynx 220. A person initially inserting the guide tube264 and guide rod 250 into the patient's mouth 212 can visuallyascertain when the guide tube and guide rod have moved to the positionillustrated in FIG. 3.

When the guide tube 264 and guide rod 250 have been positioned in thismanner relative to the patient's mouth 212 and pharynx 220, thepositioning apparatus 256 is assembled. To assemble the positioningapparatus, the rod portion 314 of the upper section 280 istelescopically inserted into the chamber 288 in the body section 286 ofthe positioning apparatus. Contemporaneously therewith, the locatingportion 302 of the positioning apparatus 296 is moved into engagementwith the patient's Adam's apple 234. The base section 278 and uppersection 280 of the positioning apparatus 256 are moved axially along theguide tube 264 and support rod 298 until the base section and uppersection of the positioning apparatus 256 are adjacent to the patient'schin 310 (FIG. 4). At this time, the coincident central axes of the rodportion 314 and body section 286 of the positioning apparatus 256 willextend perpendicular to the central axes of the guide tube 264 andsupport rod 298.

The magnet 260 is then positioned immediately beneath the patient'sAdam's apple 234. This enables the magnetic field from the magnet 260 toextend leftward and upward (as viewed in FIG. 4) to the entrance to thepatient's larynx 230. This results in the magnet 260 and positioningapparatus 256 being disposed in the orientation illustrated in FIG. 3relative to the patient.

Once the positioning apparatus 256, guide tube 264 and guide rod 250have been moved to the positions shown in FIG. 3 relative to thepatient's head 210, the person using the positioning apparatus 256visually determines the distance between the patient's Adam's apple 234and the patient's mouth 212. This is accomplished by viewing the indicia324 (FIG. 6) on the rod portion 314 of the positioning apparatus 256. Bydetermining which of the bands 330-340 is aligned with the end surface328 on the body section 286 of the positioning apparatus 256, theoperator determines the distance between the patient's Adam's apple andthe patient's mouth. The distance which the guide rod 250 must be movedinto the patient's trachea 228 is a direct function of the distancebetween the patient's Adam's apple 234 and the patient's mouth 212.

The operator then begins to manually apply force against the rightward(as viewed in FIG. 4) portion of the guide rod 250 while holding theguide tube 264 against movement. This results in the leading end portion252 of the guide rod moving downward toward the entrance to thepatient's larynx 230. As the guide rod 250 begins to move downward, thebent leading end portion 268 of the guide tube 60 directs the leadingend portion 252 of the guide rod 80 downward around the patient'sepiglottis 242 in a direction toward the entrance to the larynx 230.

It is contemplated that the resiliently deflectable guide rod 250 willinitially be formed with a bend which is a continuation of the bend inthe leading end portion of the guide tube 264. Therefore, the naturalresilience of the guide rod 250 will tend to cause the guide rod to bendrightward toward the patient's Adam's apple as the leading end portion252 of the guide rod begins to move downward toward the larynx 230.

As the leading end portion 252 of the guide rod 250 approaches theentrance to the larynx 230, the field emanating from the magnet 260attracts the leading end portion 252 of the guide rod 250. The magneticattraction forces applied to the leading end portion 252 of the guiderod 250 also promote rightward (as viewed in FIG. 4) bending of theguide rod 250 toward the patient's Adam's apple 234. Thus, the combinedeffect of the magnet 260 and the natural resilience of the preformedguide rod 250 urge the leading end portions 52 of the guide rod 250toward the entrance to the larynx 230 and away from the adjacententrance to the esophagus 226. This ensures that the leading end portion252 of the guide rod 250 enters the trachea 228 rather than theesophagus 226. If desired, the magnet 260 could be positioned above oron the patient's Adam's apple 234 and then moved downward as the guiderod 250 advances.

If desired, the flexible guide rod 250 could initially be formed with astraight configuration and only the magnet 260 would steer the leadingend portion 252 of the guide rod into the entrance to the trachea 228.Alternatively, the use of the magnet 260 could be eliminated and onlythe preformed configuration of the guide rod 250 would be used to directthe leading end portion 252 of the guide rod into the entrance to thetrachea 228. However, it is believed that it will be preferred to useboth the preformed configuration of the guide rod 250 and the magnet 260to direct the leading end portion 252 of the guide rod into thepatient's trachea 228.

The colored bands 342-350 (FIG. 8) on the guide rod 250 cooperate withthe end surface 356 (FIG. 4) of the guide tube 264 to provide anindication of the location of the leading end portion 252 of the guiderod relative to the patient's Adam's apple 234. As the leading endportion 252 of the guide rod 250 moves downward from the position shownin FIG. 3 toward the entrance to the larynx 230, the indicia bands342-350 will move toward the end surface 356 of the guide rod 250. Asthe leading end portion 252 of the guide rod 250 moves through theentrance to the larynx 230, the indicia on the guide rod 250 will beapproaching the end surface 356 of the guide tube 264.

Continued axial movement of the guide rod 250 relative to the stationaryguide tube 264 moves the leading end portion 252 of the guide rod to aposition immediately above the patient's vocal cords 232. As thisoccurs, the leading end portion 252 of the guide rod 250 is stronglyattracted by the magnetic field emanating from the magnet 260. Due tothe approach of the indicia on the guide rod 250 toward the end surface356 of the guide tube 264, the operator realizes that the leading endportion 252 of the guide rod 250 is adjacent to the magnet 260 and movesthe magnet downward (as viewed in FIG. 4) along the neck 216 of thepatient as the guide rod 250 continues to be moved leftward through thestationary guide tube 264. As the magnet 260 is manually moved downward(as viewed in FIG. 4) with the leading end portion 252 of the guide rod250, the magnet continues to attract the leading end portion of theguide rod.

One of the bands 330-340, having a particular color, for instance, red,on the rod portion 314 (FIG. 6) will be adjacent to the end surface 328on the body section of the positioning apparatus 256. When acorrespondingly colored band, that is, when the red band 344 on theguide rod 250 (FIG. 8), is partially covered by the guide tube 264 andextends axially outward from the end surface 356, the operator will knowthat the leading end portion 252 of the guide rod 250 will have movedpast the vocal 232 to the desired position relative to the patient'strachea. Insertion of the guide rod 250 into the guide tube 264 is theninterrupted.

After the guide rod 250 has been inserted for the desired distance intothe patient's trachea 228, the guide tube 264 and positioning apparatus256 are separated from the guide rod 250. During separation of the guidetube 264 and positioning apparatus 256 from the guide rod 250, the guiderod is maintained stationary relative to a patient's trachea 228. In theillustrated embodiment of the invention, the guide tube 264 is merelymoved rightward (as viewed in FIG. 4) along the stationary guide rod 250to disengage the guide tube and the positioning apparatus from the guiderod.

If desired, a slot could be provided in the guide tube 264 to facilitatedisengagement of the guide tube from the guide rod. A corresponding slotcould be formed in the end section 316 of the positioning apparatus 256.The slots in the guide tube 264 and end section 316 could be partiallyor fully blocked during insertion of the guide rod 250 into the guidetube 264. When the guide tube 264 is to be separated from the guide rod250, that is after the guide rod has been inserted for the desireddistance into the patient's trachea 228, latch or closure members forthe slots could be moved to open positions and the guide tube 264 andapparatus 256 moved out of engagement with the stationary guide rod 250.

Once the guide tube 264 and positioning apparatus 256 have beendisengaged from the guide rod 250, the guide rod is utilized to guidemovement of the tracheal tube 238 into the patient's trachea 228. Thetracheal tube 238 has a substantially larger diameter than the guidetube 264 to provide for a relatively large central opening through whichair or other gas may pass into the patient's trachea 228.

When the tracheal tube 238 is to be moved into the patient's trachea228, the guide rod 250 is telescopically inserted into the leading endof the tracheal tube. At this time, the right end (as viewed in FIG. 4)of the guide rod 250 will extend beyond the far right end of thetracheal tube 238. Therefore, the guide rod 250 can be manually graspedand the tracheal tube 238 moved axially along the guide rod while theguide rod remains stationary relative to the patient's trachea 228.

The tracheal tube 238 is moved leftward, in the manner indicated by thearrow in FIG. 9, along the stationary guide rod 250 into the patient'smouth 212. The tracheal tube 238 is then moved around the bend 360 inthe stationary guide rod 250 and into the patient's trachea 228. Sincethe guide rod 250 extends from the patient's pharynx 220 into thetrachea 228, the guide rod 250 blocks movement of the leading endportion of the tracheal tube 238 into the patient's esophagus 226. Theguide rod 250 acts as a track along which the tracheal tube 238 movesinto the patient's larynx 230 and not into the adjacent esophagus 226.

As the leading end portion of the tracheal tube 238 approaches and movespast the vocal cords 232, the guide rod 250 guides movement of theleading end portion of the tracheal tube in such a manner as to minimizeirritation of the vocal cords. Thus, the guide rod 250 centers theleading end portion of the tracheal tube 238 in the space between thevocal cords. By lubricating the leading end portion of the tracheal tube238 and centering the leading end portion of the tracheal tube in thespace between the vocal cords 232, the tracheal tube can be moved intothe patient's trachea 228 with a minimal amount of irritation to thevocal cords.

As the tracheal tube 238 is moved through the patient's larynx 230, themagnet 260 is disposed adjacent to the leading end portion 252 of theguide rod 250. Therefore, the leading end portion 252 of the guide rod250 is attracted by the magnet 260 and tends to remain stationary in thepatient's trachea 228. As the tracheal tube 238 is inserted into thepatient's trachea 228, the leading end portion of the tracheal tube 238moves past the leading end portion 252 of the guide rod 250. As thisoccurs, the leading end portion 252 of the guide rod 250 is slightlycompressed and moves into the tracheal tube 238. Once the tracheal tube238 has moved to a desired position relative to the trachea 228, theguide rod 250 is withdrawn from the tracheal tube 238 while the trachealtube is maintained stationary relative to the patient's trachea.

In the embodiment of the invention illustrated in FIGS. 4-10, the magnet260 (FIG. 4) is utilized to attract the leading end portion 252 of theguide rod 250. However, it is contemplated that the magnet 260 could beused for other purposes if desired. For example, the magnet 260 could beused to position a suture anchor relative to body tissue.

When the magnet 260 is to be utilized to position a suture anchorrelative to body tissue, a leading end portion of the suture anchor isformed of a magnetizable material, such a ferrite. Alternatively, theleading end portion of the suture anchor could be formed of a magneticmaterial such as cobalt, neodymium, cerium, praseodymium, and/orsamarium. If this was done, the magnet 260 would be oriented relative tothe magnet on the suture anchor to have a pole of the magnet 260 ofopposite polarity to the leading end of the suture anchor toward thesuture anchor.

The trailing end portion of the suture anchor may be formed of anonmagnetic material, such as a biodegradable polymer. The suture wouldextend through an opening in the nonmagnetic material of the trailingend portion of the suture anchor. Once the suture anchor had been movedto a desired position relative to body tissue by attraction of themagnet 260 for the leading end portion of the suture anchor, the leadingend portion of the suture anchor may be separated from the trailing endportion of the suture anchor. The leading end portion of the sutureanchor could then be removed from the patient's body to eliminate thepossibility of an undesired interaction in the future with a magneticfield device, such as a magnetic resonance imaging device (MRI). Thesuture would be held in place by the nonmagnetic trailing end portion ofthe suture anchor.

Embodiment of FIG. 11

In the embodiment of the invention illustrated in FIGS. 4-10, a guidetube 264 is utilized to guide movement of the guide rod 250 as the guiderod is moved from the patient's pharynx 220 into the patient's trachea228. The guide tube 264 is then removed and a tracheal tube 238 is slidalong the guide rod 250 into the patient's trachea. In the embodiment ofthe invention illustrated in FIG. 11, the tracheal tube is used to guidemovement of the guide rod into the patient's trachea. This eliminatesthe need for a separate guide tube. Since the embodiment of theinvention illustrated in FIG. 11 is generally similar to the embodimentof the invention illustrated in FIGS. 4-9, similar numerals will beutilized to designate similar components, the suffix letter “a” beingassociated being associated with the numerals of FIG. 11 to avoidconfusion.

A patient's head 210 a (FIG. 11) includes a mouth 212 a which isconnected with a throat 214 a in a neck 216 a of the patient. A pharynx220 a is connected with an esophagus 226 a and a trachea 228 a. A larynx230 a forms an upper end portion of the trachea 228 a and contains vocalcords 232 a. An Adam's apple 234 a is formed by laminae of cartilage inthe patient's larynx 230 a.

A positioning apparatus 256 a is utilized to position a tracheal tube238 a and a guide rod or wire 250 a during insertion of the guide rodand during insertion of the tracheal tube into the patient's trachea 228a. The tracheal tube 238 a (FIG. 11) is flexible and is formed of aresilient polymeric material. The tracheal tube 238 a is initiallyformed with a bend 380 in a leading end portion of the tracheal tube.When the tracheal tube 238 a is released or unrestrained, the naturalresilience of the tracheal tube causes the bend 380 to form in themanner illustrated in FIG. 10. However, the tracheal tube 238 a isflexible so that the bend 380 is easily removed from the tracheal tubeby the application of a relatively small force or pressure against theleading end portion of the tracheal tube.

In the embodiment of the invention illustrated in FIG. 10, the bend 380in the tracheal tube 238 a has a greater extent than a correspondingbend in a leading end section 268 of the guide tube 264 (FIG. 4). Ifdesired, the bend in the tracheal tube 238 a (FIG. 1) could be shortenedso that the leading end portion of the tracheal tube 238 a has aconfiguration which corresponds to the configuration of the guide tube264 of FIG. 4.

The positioning apparatus 256 a (FIG. 1) includes a base section 278 aand an upper section 280 a. A rod portion 314 a of the upper section 280a is telescopically received in a chamber 288 a in the base section 278a. Indicia 324 a on the rod portion 314 a cooperates with a body section286 a of the base section 278 a to provide a visual indication of thedistance between the patient's Adam's apple 234 a and the patient'smouth 212 a in the manner previously described in conjunction with thepositioning apparatus of FIG. 4.

The base section 278 a of the positioning apparatus 256 a includes apositioning section 96 a which engages the patient's Adam's apple 234 a.The positioning section 96 a includes a locating portion 302 a whichengages the patient's Adam's apple 234 a. The locating portion 302 aincludes a dome 304 a and a soft annular collar 306 a. Rather than usingthe collar 306 a, it may be preferred to utilize a pair of positioningfingers which engage the neck 216 a of the patient at laterally oppositesides of the Adam's apple 234 a.

Indicia (not shown) is provided on the guide rod 250 a to indicate theposition of the guide rod relative to a proximal end of the trachealtube 238 a, that is, the right end as viewed in FIG. 1. It should beunderstood that the tracheal tube 238 a and the guide rod 250 a extendtoward the right from the fragmentary end portions illustrated inFIG. 1. The indicia on the guide rod 250 a is formed by bandscorresponding to the bands 342-350 of FIG. 8. Rather than cooperatingwith the end 156 (FIG. 4) of a guide tube 264, the bands on the guiderod 250 a (FIG. 11) cooperate with an end (not shown) of the trachealtube 238 a to indicate the position of the guide rod 250 a relative tothe tracheal tube 238 a.

When the guide rod 250 a is to be moved from the patient's pharynx 220 ainto the patient's trachea 228 a, the guide rod is moved axiallyrelative to the stationary tracheal tube 238 a. As this occurs, aleading end portion 252 a of the guide rod 250 a moves downward (asviewed in FIG. 11) past the patient's vocal cords or folds 32 a and intothe patient's trachea. As the leading end portion 252 a of the guide rod250 a moves from the patient's pharynx 220 a into the patient's trachea228 a, the leading end portion of the guide rod gently deflects bodytissue. For example, the leading end portion 252 a of the guide rod 250a may gently engage and slightly deflect the patient's vocal cords orfolds 32 a.

A magnet 260 a is initially positioned adjacent to the patient's Adam'sapple 234 a, in the manner indicated in dashed lines in FIG. 11. Ferriteparticles in the soft, resiliently compressible leading end portion 252a of the guide wire 250 a are attracted by the magnet 260 a. Thisattraction causes the leading end portion 252 a of the guide wire 250 ato move into the open upper end portion of the trachea 228 rather thaninto the adjacent open upper end portion of the esophagus 226 a. Inaddition, movement of the leading end portion 252 a of the guide wire250 a into the open upper end portion of the trachea 228 is promoted bythe bend 380 in the tracheal tube 238 a. If desired, the magnet 260 acould initially be positioned on or above the patient's Adam's apple 234a and moved downward from there.

As the guide wire continues to be inserted into the tracheal tube 238 a,the guide wire moves downward in the patient's trachea 228 a. At thesame time, the magnet 260 a is moved downward along the outer side ofthe patient's neck 216 a. The indicia (not shown) on the guide rod 250 aprovides an indication to an operator of the position of the leading endportion 252 a of the guide rod. This enables the operator to follow theleading end portion 252 a of the guide rod 250 a with the magnet 260 aas the guide rod continues to be moved through the tracheal tube 238 ainto the patient's trachea 228 a.

Once the guide rod 250 a has been moved for a desired distance into thetrachea 228 a, the guide rod 250 a is held stationary relative to thepatient's trachea. The tracheal tube 238 a is then moved axially towardthe left (as viewed in FIG. 11) and downward into the patient's trachea228 a. During this downward movement of the tracheal tube 238 a, theguide rod 250 a blocks sidewise movement of the leading end of thetracheal tube so that the tracheal tube enters the larynx 230 a ratherthan the adjacent open upper end of the esophagus 226 a. As the trachealtube 238 a continues to be inserted into the trachea 228 a, the leadingend of the tracheal tube 238 a moves into engagement with the leadingend portion 252 a of the guide rod 250 a. The leading end portion 252 aof the guide rod 250 a is then compressed somewhat by the leading endportion of the tracheal tube 238 a and moves into the passage in thetracheal tube. The tracheal tube 238 a is then moved further into thetrachea 228 a.

After the tracheal tube 238 a has been positioned relative to thepatient's trachea, the guide rod 250 a is withdrawn from the trachealtube while the tracheal tube remains stationary relative to thepatient's trachea 228 a. The positioning apparatus 256 a is thenseparated from the tracheal tube 238 a.

Embodiment of FIG. 12

In the embodiment of the invention illustrated in FIG. 1, a leading endportion 52 of the guide wire or rod 50 is inserted between the vocalcords or folds in the respiratory system 11 of the patient. It'scontemplated that movement of the leading end portion 52 of the guiderod 50 between the vocal cords 32 to a desired depth in the patient'strachea 28 may be facilitated by transmitting images of body tissueadjacent to the leading end portion of the guide rod to a viewinglocation outside of the patient's body. Since the embodiment of theinvention illustrated in FIG. 12 is generally similar in the embodimentinvention illustrated in FIGS. 1 and 2, similar numerals will beutilized to designate similar components, the suffix letter “b” beingadded to the numerals of FIG. 12 in order to avoid confusion.

A positioning apparatus 56 b is utilized to position a flexible guiderod 50 b relative to the patient's respiratory system 11 b. Thepositioning apparatus 56 b includes a base section 78 b which isconnected with a positioning section 96 b. The positioning section 96 bengages the patient's Adam's apple 34 b. An arcuate member 108 b isconnected with the base section 78 b. The guide rod 50 b is moveablerelative to a guide section 114 b connected with arcuate member 108 b.The construction and the manner of using the positioning apparatus 56 band guide rod 50 b is the same as was previously described inconjunction with the embodiment invention illustrated in FIGS. 1 and 2.

In accordance with a feature the embodiment invention illustrated inFIG. 12, light from a light source 400 is conducted through a fiberoptic tube 402 to a leading end portion 52 b of the flexible guide rod50 b. The light transmitted from the light source 400 through the fiberoptic tube 402 to the leading end portion 52 b of the guide rod 50 b isdirected from the leading end portion of the guide rod on to adjacentbody tissue, in the manner indicated schematically at 404 in FIG. 12. Ifdesired, a plurality of fiber optic tubes 402 could be provided toconduct light from the light source 400 to the leading end portion 52 bof the guide rod. These fiber optic tubes could be bundled together orcould be spaced part at the leading end portion 52 b of the guide rod 50b.

The light 404 which illuminates the body tissue immediately ahead of theleading end portion 52 b of the guide rod 50 b is reflected from thebody tissue and is transmitted through a fiber optic tube 408 to the eye410 of a viewer. This results in the transmission of an image of thebody tissue adjacent to the leading end portion 52 b of the guide rod 50b to the viewer to facilitate visualization, by the viewer, of the bodytissue. If desired, a plurality of fiber optic tubes 408 could beprovided to conduct light from the leading end portion 52 b of the guiderod to the eye 410 of the viewer. These fiber optic tubes could bebundled together or could be spaced apart at the leading end portion 52b of the guide rod 50 b.

By visualizing the body tissue immediately ahead of the leading endportion 52 b of the guide rod 50 b, the viewer can determine thelocation of the leading end portion of the guide rod relative to thelarynx 30 b and vocal chords 32 b of a patient as the leading endportion of the guide rod moves into the larynx and between the vocalchords. Since the light 404 illuminates body tissue immediately ahead ofthe leading end portion 52 b of the guide rod 50 b, the light enablesthe viewer to continuously visualize where the leading end portion 52 bof the guide rod 50 b is located along the insertion path in therespiratory system 11 b of the patient.

In the embodiment invention illustrated in FIG. 12, the fiber optictubes 402 and 408 extend through the guide rod 50 b to enable an imageof body tissue immediately ahead of the leading end portion 52 b of theguide rod to be transmitted to a viewer. It is contemplated thatmovement of a tracheal tube, corresponding to tracheal tube 38 of FIG.2, along the guide rod 50 b into the patient's respiratory system 11 bwill be facilitated by illuminating body tissue immediately ahead of theleading end portion of the tracheal tube. Therefore, the side wall ofthe tracheal tube may be provided with fiber optic tubes which transmitlight from a light source, such as a light source 400, to a locationimmediately ahead of the leading end portion of the tracheal tube andtransmit an image of illuminated body tissue immediately ahead of theleading end portion of tracheal tube to a viewer.

As the tracheal tube is moved along the guide rod 50 b into thepatient's respiratory system, in the manner previously explained inconjunction with the embodiment invention illustrated in FIG. 2, bodytissue immediately ahead of the leading end portion 52 b of thestationary guide rod 50 b is illuminated and body tissue immediatelyahead of the tracheal tube is illuminated. Therefore, as the leading endportion of the tracheal tube approaches the vocal chords 32 b, a surgeonor other viewer can easily determine the location of the leading endportion of the tracheal tube relative to the vocal chords. As theleading end portion of the tracheal tube approaches the leading endportion 52 b of the guide rod, the image transmitted to the viewer willbe of body tissue illuminated by both light transmitted from the leadingend portion 52 b of the guide rod and light transmitted from the leadingend portion of the tracheal tube.

The leading end portion of the tracheal tube may be inserted intotrachea 28 b of a patient for greater distance than the distance whichthe guide rod 50 b is inserted into the trachea. As the leading endportion of the tracheal tube moves past the leading end portion 52 b ofthe guide rod 50 b, illumination from the leading end portion of theguide rod 50 b will be at least partially blocked from transmission backto the viewer through fiber optics in the tracheal tube. Therefore, theviewer will easily be able to determine when the leading end portion ofthe tracheal tube has moved past the leading end portion of the guiderod 50 b.

Although the eye 410 of a viewer has been schematically illustrated inFIG. 12, it is contemplated that the image transmitted through the fiberoptic tube 408 may be displayed on a viewing screen. If this was done,the image transmitted through the fiber optic tube 408 would betransmitted to a computer and a viewing screen associated with thecomputer would display an image of the body tissue immediately ahead ofthe leading end portion 52 b of the guide rod 50 b. As the tracheal tubeis moved along the guide rod into the patient's respiratory system 11 b,an image of body tissue immediately ahead of the leading end portion ofthe tracheal tube may also be transmitted to the computer.

A second computer screen may be utilized to display an image of the bodytissue immediately ahead of the leading end portion of the trachealtube. If this is done, the surgeon or other viewer would be able to seean image of body tissue immediately ahead the leading end portion 52 bof the guide rod 50 b and an image of body tissue immediately ahead ofthe leading end portion of the tracheal tube. When simultaneouslyviewing the two images on two separate screens or on separate portionsof a single screen, the surgeon or other viewer would be able todetermine the positions of the leading end portions of both the guiderod 50 b and the tracheal tube relative to each other and to therespiratory system 11 b of a patient.

Although it's preferred to utilize the tracheal tube and it's associatedillumination system in conjunction with the guide rod 50 b, the trachealtube may be utilized by itself. Thus, fiber optic tubes which extendthrough the side wall of the tracheal tube and correspond to the fiberoptic tubes 402 and 408 of FIG. 12, would provide an image of the bodytissue immediately ahead of the leading end portion of the tracheal tubeas the tracheal tube is moved into the patient's respiratory system 11 balong an insertion path. The image transmitted from the leading endportion of the tracheal tube to the eye of the viewer or to a displayscreen would enable a surgeon or other viewer to determine the locationof the leading end portion of the tracheal tube relative to thepatient's respiratory system 11 b.

When the tracheal tube and it's associated illumination and imagetransmitting systems are utilized without guide rod 50 b, thepositioning apparatus 56 b may be modified to guide movement of thetracheal tube in much the same manner as in which the positioningapparatus 56 b is utilized to guide movement of the guide rod 50 b. Ifthis is done, colored bands or other indicia could be provided on thetracheal tube to indicate the position of the tracheal tube in the samemanner as previously discussed in connection with the guide rods 50 and250.

It is contemplated that the positioning apparatus 56 b may be used forpurposes other than tracheal intubination. Thus, the positioningapparatus 56 b may be used to position devices other than the guide rod50 b during endoscopic, arthroscopic, or fiber optic surgery at any oneof many locations in a patient's body. A magnet, similar to the magnet260 of FIGS. 4 and 7 may be used to steer a leading end portion of thedevice being positioned in the patient's body. The leading end portionof the device being positioned in the patient's body may be located at aposition adjacent to or spaced a desired distance from a positioningsection, corresponding to the positioning section 96 b, by the use ofsuitable indicia, which may be similar to the indicia used inconjunction with the guide rods 50 and 250.

When the positioning apparatus 50 b is to be used to position a medicantor a device of any desired type at a selected location in a patient'sbody, the positioning section 96 b is positioned in engagement with aselected portion of the patient's body. The selected portion of thepatient's body may be a portion of the patient's body other than theAdam's apple 34 b. Although it is believed that it will probably bepreferred to engage an exterior surface on the patient's body with thepositioning section 96 b, the positioning section could be placed inengagement with a surface disposed within the patient's body if desired.

While the positioning section 96 b is engaging the selected portion ofthe patient's body, the guide rod 50 b or a similar elongated member ismoved relative to the guide section 114 b connected with the arcuatemember 108 b. The leading end portion 52 b of the guide rod 50 b orsimilar elongated member is then moved into the patient's body. Theleading end portion 52 b may be moved into the patient's body through anaturally occurring opening or through an incision formed in thepatient's body.

The image transmitted through the guide rod or similar elongated member50 b to the viewer will indicate when the leading end portion 52 b hasmoved to a desired position in the patient's body. Once the leading endportion 52 b of the guide rod or similar elongated member 50 b has movedto the desired position relative to the patient's body, any desiredprocedure may be performed in the patient's body. For example, asurgical procedure could be conducted with one or more devices connectedwith the leading end portion 52 b of the guide rod or similar elongatedmember. The positioning apparatus 56 b may be used to position atherapeutic agent or device at the desired position in the patient'sbody.

Embodiment of FIGS. 13 and 14

In the embodiment invention illustrated in FIG. 12, the light source 400and fiber optic tube 402 function as an emitter which emits illumination404 onto body tissue immediately ahead of the leading end portion 52 bof the guide rod 50 b to facilitate visualization of the body tissue. Inthe embodiment invention illustrated in FIGS. 13 and 14, a plurality ofemitters are positioned adjacent to an outer side surface of thepatient's neck. A detector on a leading end portion of a guide rod ismoved into the patient's respiratory system. Since the embodimentinvention illustrated in FIGS. 13 and 14 is generally similar to theembodiment invention illustrated in FIGS. 1, 2 and 12, similar numeralswill be utilized to identify similar components, the suffix letter “c”being associated with the numerals of FIGS. 13 and 14 to avoidconfusion.

A positioning apparatus 56 c (FIG. 13) is utilized to position aflexible guide wire or rod 50 c relative to a respiratory system 11 c ofa patient. The respiratory system 11 c of the patient extends from themouth 12 c through a larynx 30 c to a trachea 28 c of the patient. Thepositioning apparatus 56 c engages an Adam's apple 34 c of a patient tolocate the guide rod 50 c relative to the patient's respiratory system11 c.

The positioning apparatus 56 c has the same general construction andmode operation as the positioning apparatus 56 of FIGS. 1 and 2. Thepositioning apparatus 56 c includes a base section 78 c having a bodysection 86 c which is pivotally connected with a positioning section 96c. The positioning section 96 c engages an outer surface of the neck ofthe patient adjacent to the Adam's apple 34 c to locate the positioningapparatus 56 c relative to the patient's respiratory system 11 c. Ifdesired, the positioning apparatus 96 c could include a collar whichwould extend around the patient's Adam's apple 34 c in the matterpreviously described in conjunction with the embodiment inventionillustrated in FIG. 7. Alternatively, the positioning apparatus 96 ccould include a pair of fingers which engage opposite lateral sides ofthe patient's Adam's apple.

An arcuate member 108 c is connected with and is moveable relative tothe body section 86 c of the positioning apparatus 56 c at a connection110 c. A flexible guide rod 50 c is axially slidable relative to a guidesection 114 c which is connected with the arcuate member 108 c. Theconstruction of the positioning apparatus 56 c is the same as waspreviously described in conjunction with the embodiment inventionillustrated in FIGS. 1 and 2.

In accordance with a feature of the embodiment invention illustrated inFIG. 13, a sensor assembly 420 is provided to inform a surgeon or otheruser of the positioning apparatus 56 c, of the position of the guide rod50 c relative to the patient's respiratory system 11 c. The sensorassembly 420 includes an emitter portion 424 (FIG. 14) which provides anoutput and a detector portion 426 (FIG. 13) which responds to the outputfrom the emitter portion 424. In the embodiment of invention illustratedin FIGS. 13 and 14, the emitter portion 424 is positioned on an outerside surface of the neck of the patient adjacent to the Adam's apple 34c. The detector portion 426 is connected with a leading end portion 52 cof a guide rod 50 c. However, it should be understood that the emitterportion 424 could be connected with the guide rod 50 c and the detectorportion 426 positioned adjacent to the Adam's apple 34 c of the patient.

In the illustrated embodiment invention, the emitter portion 424 of thesensor assembly 420 includes a plurality of emitters units 430 which arepositioned an array which extends around the Adam's apple 34 c (FIG. 14)of the patient. The emitter units 430 are secured to the neck of thepatient by a suitable adhesive. The emitter units 430 may be positionedin any desired spatial relationship with the patient's Adam's apple 34c.

Alternatively, the emitter units 430 may be connected with thepositioning section 96 c. Thus, the positioning section 96 c of thepositioning apparatus 56 c is provided with three fingers which engagethe neck of the patient adjacent to the Adam's apple 34 c. Each of theemitter units 430 may be connected with one of the fingers of thepositioning section 96 c. The positioning section 96 c would accuratelylocate the emitter units 430 relative to the patient's Adam's apple 34c.

In the embodiment of the invention illustrated in FIG. 13, thepositioning section 96 c engages the Adam's apple 34 c and the emitterunits are disposed in a generally circular array which extends aroundthe Adam's apple 34 c. However, it should be understood that the emitterunits 430 could be connected with a collar, similar to the collar 306 ofFIG. 7. The collar may be connected with the positioning section 96 c(FIG. 13). Alternatively, the collar could be separate from thepositioning apparatus.

Although it is preferred to utilize the positioning apparatus 56 c inconjunction with the guide rod 50 c, in the manner previously describedin conjunction with the embodiment of the invention illustrated in FIG.1, it is contemplated that the positioning apparatus 56 c may be omittedand the guide rod 50 c moved along an insertion path into the patient'srespiratory system without benefit of the assistance provided by thepositioning apparatus. If this is done, the emitter units 430 (FIG. 14)could be connected with a support structure which holds the emitterunits 430 in a fixed relationship relative to each other and facilitatespositioning of the emitter units relative to the patient's Adam's apple34 c. For example, a positioning section having a plurality of fingers,could be manually centered on the patient's Adam's apple 34 c to locatethe emitter units 430 relative to the Adam's apple. Similarly, a collar,corresponding to the collar 306 of FIG. 7, could be provided on acircular or oval support which would extend around the patient's Adam'sapple 34 c to locate the emitter units 430 relative to the patient'sAdam's apple. Regardless of the specific structure which is utilized toposition the emitter units 430 relative to each other, this apparatuscould be manually positioned relative to the patient's Adam's apple 34 cwithout being connected with a positioning apparatus having aconstruction similar to the construction of the positioning apparatus 56c.

When the positioning apparatus 56 c is to be utilized to assist in thepositioning of the guide rod 50 c relative to the patient's respiratorysystem 11 c, the positioning section 96 c is positioned in engagementwith the patient's Adam's apple 34 c. The emitter units 430 may besuitably mounted on the positioning section 96 c. This would locate theemitter units 430 relative to the patient's Adam's apple 34 c (FIG. 14).It should be understood that the emitter units 430 could be mounted on asupport other than the positioning section 96 c if desired. Of course,the emitter units 430 may be secured directly to the neck of the patientby a suitable adhesive, as illustrated in FIG. 14. When this is done, asupport structure interconnecting the emitter units 430 may be used tofacilitate positioning of the emitter units relative to the patient'sAdam's apple 34 c.

The arcuate member 108 c is then positioned axially along the bodysection 86 c. When the arcuate member 108 c has been moved to a desiredposition relative to the body section 86 c, the connection 110 c issecured to hold the arcuate member against axial movement along the bodysection. The arcuate member 108 c is then moved relative to the bodysection 86 c to position the guide section 114 c and the leading endportion 52 c of the guide rod 50 c in alignment with the entrance to thepatient's mouth 11 c. The guide rod 50 c is then moved into thepatient's respiratory system 11 c along an insertion path.

As the guide rod 50 c is moved along the insertion path into thepatient's respiratory system 11 c, the detector portion 426 of thesensor assembly 420 approaches the emitter units 430. As this occurs,the detector portion provides an output over leads 434 and 436 to acomputer or micro processor 438. The computer or micro processor has anoutput, indicated schematically at 440, which can be viewed by a surgeonor other individual moving the guide rod 50 c along the insertion pathinto the patient's respiratory system 11 c.

The computer output may include a display having a schematicillustration of a typical patient's respiratory system. The positions ofthe emitter units 430 relative to the typical respiratory system and theposition of the detector portion 426 relative to the emitter units 430would be indicated on the display. Thus, a display screen connected withthe computer 438 has an illustration representative of the patient'srespiratory system 11 c. A plurality of indicators are provided on thedisplay screen to indicate the positions of the emitter units 430relative to the schematic illustration of the patient's trachea. Anindicator is provided to indicate the position of the leading end of theguide rod 50 c relative to the schematic illustration of the patient'srespiratory system. The display screen has one illustration of thepatient's respiratory system 11 c as viewed in a medial plane andanother illustration of the patient's respiratory system as viewed in afrontal plane. Indicators corresponding to the emitter units 430 anddetector 426 are provided in both illustrations.

As the leading end portion 52 c of the guide rod 50 c moves along theinsertion path into the patient's respiratory system 12 c, the detectorportion 426 of the sensor assembly 420 approaches the emitter portion424 of the sensor assembly. As this occurs, the strength of the outputfrom the detector portion 426 through the leads 434 and 436 increases.As the strength of the output from the detector portion 426 increases,the computer and the associated display indicates to an operator of theapparatus 56 c that the leading end portion 52 c of the guide rod 50 cis approaching a junction between the patient's esophagus 26 c and thepharynx.

If the guide rod continues movement along its intended course ofinsertion, that is, into the patient's larynx 30 c and not into thepatient's esophagus 26 c, the strength of the output signal provided bythe detector portion 426 will increase. However, if the leading endportion 52 c of the guide rod 50 c enters the patient's esophagus 26 c,the strength of the output signal from the detector portion 426 willdecrease. The decreasing strength of the signal from the detectorportion 426 provides a clear indication to the operator of the apparatus56 c that the leading end portion 52 c of the guide rod 50 c hasdeviated from its intended course.

As the detector portion 426 of the sensor assembly 420 moves between thepatient's vocal chords 32 c into alignment with the emitter portion 424of the sensor assembly 420, the strength of the signal transmitted tothe computer 438 will be maximized. As the guide rod 50 c continues tobe moved into the patient's trachea 28 c along the insertion path, thestrength of the signal transmitted through the leads 434 and 436 to thecomputer 438 will decrease to indicate to the operator of the apparatus56 c that the leading end portion 52 c of the guide rod has moved pastthe patient's Adam's apple 34 c.

Although it is believed that it will be preferred to display the outputof the computer 438 in association with one or more illustrations of thepatient's respiratory system 11 c in the manner previously mentioned,the computer output information could be transmitted in a differentmanner if desired. For example, the computer 438 could have a lightdisplay system which indicates how close the detector 426 is to theemitter units 430. Similarly, the computer 438 could have an audiooutput which indicates how close the detector 426 is to the emitterunits. Of course, the computer could have an output which is acombination of a display screen, lights and/or audio signals.

Once the guide rod 50 c has been moved to the desired position along thepatient's respiratory system 11 c, the positioning apparatus 56 c may bedisconnected from the guide rod 50 c. A tracheal tube, corresponding totracheal tube 38 of FIG. 2, is then moved along the guide rod 50 c intothe patient's trachea 28 c. The manner in which the tracheal tube ismoved along the guide rod 50 c into the patient's trachea 28 c is thesame as was previously discussed in conjunction with the embodiment ofthe invention illustrated in FIGS. 1 and 2. A magnet, corresponding tothe magnet 260 of FIGS. 4 and 7, may be utilized to steer the leadingend portion of the guide rod 50 c. If desired, an electromagnet whichcan be turned on and off may be utilized.

The tracheal tube which is utilized in association with the guide rod 50c of FIG. 13 may have the same construction as the tracheal tube 38utilized with the guide rod 50 of FIG. 2. Alternatively, the trachealtube utilized with the guide rod 50 c may have a second detectorportion, having the same construction as the detector portion 426 of theguide rod 50 c. If the tracheal tube is provided with a second detectorportion, the emitter portion 424 of the sensor assembly 420 ismaintained in position relative to the patient's Adam's apple 34 c.

By providing the tracheal tube with a second detector portion, and bymaintaining the emitter portion 424 in position relative to thepatient's Adam's apple 34 c, the output from the second detector portionmay be utilized to locate the leading end portion of the tracheal tubeas the tracheal tube is moved along the guide rod 50 c into thepatient's respiratory system 11 c. If this is done, leads, correspondingto the leads 434 and 436 would extend along the side wall of thetracheal tube from the second detector portion to the computer 438. Theoutput from the computer 438 would indicate the position of the leadingend portion of the tracheal tube relative to the emitter 424. The outputfrom the second detector portion on the leading end portion of trachealtube would indicate the position of the leading end portion of thetracheal tube relative to the position of the leading end portion of theguide rod 50 c.

The output from the computer may be a display having the constructionpreviously described in conjunction with the guide rod 50 c. Thus, adisplay screen connected with the computer 438 has an illustrationrepresentative of the patient's respiratory system 11 c. A plurality ofindicators are provided on the display screen to indicate the positionsof the emitter units 430 relative to the patient's trachea. An indicatoris provided to indicate the position of the leading end of the trachealtube relative to the patient's respiratory system. The display screenhas one illustration of the patient's respiratory system 11 c as viewedin a medial plane and another illustration of the patient's respiratorysystem as viewed in a frontal plane. Indicators corresponding to theemitter units 430 and detector on the tracheal tube are provided in bothillustrations.

In the embodiment of the invention illustrated in FIGS. 13 and 14, theemitter units 430 are magnets which emit a magnetic field. The detectorportion 426 is a magnetometer which responds to variations in thestrength of a magnetic field. Thus, the output from the detector portion426 increases as the detector portion moves closer to the patient'sAdam's apple 34 c and the magnets forming the emitter units 430. Thedetector portion 436 may be Hall effect device, magnetoresistor, or agalvanometer device. Regardless of what specific type of magnetic fieldresponsive device is utilized to form the detector portion 426 of thesensor assembly, the output from the detector portion will vary as thedistance between the leading end portion 52 c of the guide rod 50 c andthe magnets in the emitter units 430 varies.

In the embodiment of the invention illustrated in FIGS. 13 and 14, thesensor assembly 420 is the type which responds to a magnetic field.However, it is contemplated that the sensor assembly 420 could beconstructed so as to respond to other types of emissions. For example,light sources could be utilized as the emitter units 430 and thedetector portion 436 may be a photo cell which responds to variations inthe amount of light received. Alternatively, the emitter units 430 couldbe sources of radio frequency radiation and the detector portion 426could be constructed so as to have an output which varies as thedistance between the detector portion and the sources of radio frequencyradiation varies. If desired, the emitter units 430 could be ultrasonictransducers and the detector 426 could respond to ultrasonic energy.

The sensor assembly 420 has been illustrated in FIGS. 13 and 14 inassociation with the positioning apparatus 56 c. However, it should beunderstood hat the sensor assembly 420 could be utilized in associationwith the positioning apparatus 256 of FIGS. 4-10 or the positioningapparatus 256 a of FIG. 11. If this was done, the use of the magnet 260or 260 a (FIGS. 4, 7 and 11) may be eliminated to avoid interferencewith magnetic fields from the emitter units 430. Of course, if theemitter units provided outputs which were not affected by the magneticfield from the magnets 260 and 260 a, the magnets 260 and 260 a couldstill be utilized.

The positioning apparatus 56 c and sensor assembly 420 have beenillustrated in association with a tracheal intubination procedure. It iscontemplated that the positioning apparatus 56 c and/or sensor assembly420 may be used in association with other medical procedures if desired.For example, the positioning apparatus 56 c and/or sensor assembly 420may be used in the performance of endoscopic, arthroscopic or fiberoptic surgical procedures. The positioning apparatus 56 c and/or sensorassembly 420 may be used in association with surgery on joints or otherportions of a patient's body. The positioning apparatus 56 c and/orsensor assembly 420 may be used to deliver medicants to a desiredlocation in a patient's body.

Embodiments of FIGS. 15 and 16

In the embodiment of the invention illustrated in FIGS. 13 and 14, theemitter portion 424 of the sensor assembly 420 is disposed adjacent tothe outer surface of the neck of the patient while the detector portion426 of the sensor assembly is connected with the guide rod 50 c. In theembodiment of the invention illustrated in FIGS. 15 and 16, the detectorportion of the sensor assembly is disposed adjacent to the outer surfaceof the patient's neck and the emitter portion of the sensor assembly isconnected with the leading end portion of the guide rod. Since theembodiment of the invention illustrated FIGS. 15 and 16 is generallysimilar to the embodiment of the invention illustrated in FIGS. 1, 2, 13and 14, similar numerals will be utilized to identify similarcomponents, the suffix letter “d” being associated with the numerals ofFIGS. 15 and 16 to avoid confusion.

The positioning apparatus 56 d is utilized to position a flexible guiderod 50 d relative to a patient's respiratory system 11 d. Thepositioning apparatus 56 d includes a base section 78 d having a bodysection 86 d and a positioning section 96 d. An arcuate member 108 d isconnected with the body section 86 d at a connection 110 d. When thearcuate member 108 d has been moved to a desired position along the basesection 86 d, the connection 110 d is actuated to hold the member 108 dagainst axial movement along the body section 86 d. When the guidesection 114 d has been moved into alignment with the patient's mouth 12d, the connection 110 d is again actuated to hold the arcuate member 108d against movement relative to the base section 86 d.

The guide section 114 d cooperates with the flexible guide rod 50 d toposition the guide rod during movement of the guide rod into thepatient's respiratory system 11 d along an insertion path. The generalconstruction and mode of operation of the positioning apparatus 56 d isthe same as was previously described in conjunction with the positioningapparatus 56 of FIGS. 1 and 2.

In accordance with a feature of this embodiment of the invention, asensor assembly 420 d is provided to sense when the guide rod 50 d hasmoved to a desired position relative to the patient's respiratory system11 d. The sensor assembly 420 d includes a detector portion 426 d (FIG.16) and an emitter portion 424 d (FIG. 15).

The sensor portion 426 d of the sensor assembly 420 d is positioned onthe outer surface of a neck of a patient (FIG. 16) adjacent to thepatient's Adam's apple 34 d. The emitter portion 424 d is connected witha leading end portion 52 d of the guide rod 50 d (FIG. 15). The sensorportion 426 d (FIG. 16) is mounted directly on the patient's neck by asuitable adhesive. However, if desired, the sensor portion 426 d couldbe connected with the positioning section 96 d of the positioningapparatus 56 d. If this is done, when the positioning section 96 d ofthe positioning apparatus 56 d is positioned in engagement with thepatient's Adam's apple 34 d, the sensor portion 426 of the sensorassembly 420 d would also positioned relative to the patient's Adam'sapple. However, if desired, the sensor portion 426 d could be mounted ona support and positioned relative to the patient's Adam's apple 34 dindependently of the positioning section 96 d of the positioningapparatus 56 d.

The sensor portion 426 d of the sensor assembly 420 d includes aplurality of sensor units 440 which are disposed in an array around thepatient's Adam's apple 34 d (FIG. 16). The sensor units 440 have leads442 which are connected with a computer or micro processor 444. Thecomputer or micro processor 444 has an output, indicated schematicallyin 446 in FIG. 16, which is indicative of the position of the emitterportion 424 d of the sensor assembly 420 d relative to the position ofthe sensor portion 426 d of the sensor assembly. The emitter portion 424d of the sensor assembly 420 d is connected with the leading end portion52 d of the guide rod 50 d.

During use of the positioning apparatus 56 d, the leading end portion 52d of the flexible guide rod 50 d is aligned with the mouth 12 d of thepatient. The guide rod 50 d is then moved into the patient's respiratorysystem 11 d along an insertion path. As the guide rod 50 d is moved intothe patient's respiratory system 11 d, the emitter portion 424 d of thesensor assembly 420 d approaches the sensor portion 426 d of the sensorassembly 420 d. As this occurs, the strength of the output from thesensor units 440 increases.

The increasing strength of the output from the sensor units 440 resultsin a change in the output 446 from the computer 444. The output 446 fromthe computer 444 may take the form of a display which schematicallyindicates the position of the emitter portion 424 d of the sensorassembly 420 d relative to the sensor portion 426 d of the sensorassembly. Thus, a display screen for the computer 444 may have aschematic illustration representative of a typical patient's respiratorysystem. The display screen would indicate the position of the sensorportion 426 d of the sensor assembly 420 d relative to the patient'srespiratory system and the position of the emitter portion 424 d of thesensor assembly 420 d relative to the patient's respiratory system.Since the emitter portion 424 d is connected with the leading endportion 52 d of the guide rod 50 d, the display for the computer 444would indicate the position of the leading end portion 52 d of the guiderod relative to the patient's Adam's apple 34 d.

Although it is believed that the use of a display screen may bepreferred, the output 446 from the computer 444 could take a differentform if desired. For example, the computer could have an audio output.Alternatively, a display graph formed of a series of lights couldprovide a visual output. As the emitter portion 424 d approaches thesensor units 440, the number of illuminated lights in the series oflights would increase. When the emitter portion 424 d is aligned withthe center of the array of sensor units 440 and the patient's Adam'sapple 34 d, the entire series of lights would be illuminated. Of course,the output 446 from the computer 444 could include both audio and visualoutputs.

In the embodiment of the invention illustrated in FIGS. 15 and 16, theemitter portion 424 d of the sensor assembly 420 d is a magnet whichemits a magnetic field. The sensor portion 426 d of the sensor assembly420 d has an output which varies as a function of the strength of themagnetic field at the sensor units. Therefore, as the leading endportion 52 d of the guide rod 50 d approaches the patient's Adam's apple34 d, the strength of the magnetic field to the sensor units 440increases and the output transmitted to the computer 444 increases.

In the specific embodiment of the invention illustrated in FIG. 16, thesensor units 440 are Hall effect devices. However, it is contemplatedthat other known devices which respond to variations in a magnetic fieldmay be utilized in place of the Hall effect devices which form thesensor units 440. For example, magnetoresistors could be utilized as thesensor units 440 in place of the Hall effect devices.

Once the guide rod 50 d has been positioned relative to the patient'srespiratory system 11 d, the positioning apparatus 56 d is disconnectedfrom the guide rod 50 d while the guide rod is maintained stationaryrelative to the patient's respiratory system 11 d. A flexible trachealtube, corresponding to the tracheal tube 38 of FIG. 2, is then movedalong the guide rod 50 d into the patient's respiratory system 11 d. Themanner of insertion of the tracheal tube into the patient's respiratorysystem 11 d, by sliding the tracheal tube along the guide rod 50 d, isthe same as was previously described in conjunction with the embodimentof the invention illustrated in FIG. 2.

It is contemplated that the sensor portion 426 d of the sensor assembly420 d can be utilized in association with the tracheal tube. Thus, thetracheal tube can be provided with a second emitter portion having thesame construction as the emitter portion 424 d. In the embodiment of theinvention illustrated in FIGS. 15 and 16, a magnet, which emits amagnetic field, would be mounted on a leading end portion of thetracheal tube.

As the tracheal tube having an emitter, is moved along the guide rod 50d, the magnet on the leading end portion of the tracheal tube would havean effect on the sensor units 440. The effect on the magnet on thesensor units 440 increases as the leading end portion of the trachealtube approaches the patient's Adam's apple 34 d. It is contemplated thatthe tracheal tube may be inserted into the patient's trachea 28 dfurther than the guide rod 50 d. If this is done, the output from thesensor units 440 d diminishes in magnitude as the leading end portion ofthe tracheal tube is moved down the patient's trachea past the sensorunits.

Although it is preferred to utilize the sensor assembly 420 d inassociation with the positioning apparatus 56 d, the sensor assemblycould be utilized separately from the positioning apparatus. Forexample, the sensor units 440 may be mounted in an array on a separatesupport structure. The support structure would be positioned in anengagement with the exterior of the patient's neck with the array ofsensor units 440 centered about the patient's Adam's apple, in themanner illustrated schematically in FIG. 16.

The guide rod 50 d would then be moved along the patient's respiratorysystem 11 d without benefit of the positioning apparatus 56 d. As theguide rod 50 d moves along the patient's respiratory system 1 d, thestrength of the magnetic field from the emitter portion 424 d of thesensor assembly 420 d detected by the sensor units 440 would increase.This would result in an increase in the output from the sensor units 440to the computer 444. The output 446 from the computer 444 would indicateto the operator moving the guide rod 50 d, the position of the guide rodalong an insertion path into the patient's respiratory system 11 d.

Once the guide rod 50 d has been positioned in the foregoing mannerrelative to the patient's respiratory system 11 d, without benefit ofthe positioning apparatus 56 d, the tracheal tube would be moved alongthe guide rod into the patient's respiratory system 11 d. The trachealtube could have the same construction and move in the same manner as thetracheal tube 38 of FIG. 2.

Alternatively, the tracheal tube could be provided with a second emitterportion, corresponding to the emitter portion 424 d of the sensorassembly 420. Thus, a magnet could be provided on the leading endportion of the tracheal tube. As the leading end portion of the trachealtube moves along the insertion path into the patient's respiratorysystem 11 d, the magnetic field detected by the sensor units 440 wouldincrease due to the magnet connected with the leading end portion of thetracheal tube approaching the magnet on the leading end portion 52 d ofthe guide rod 50 d.

It is also contemplated that the tracheal tube could be positionedrelative to the patient's respiratory system 11 d without benefit of theguide rod 50 d. The tracheal tube would be provided with an emittercorresponding to the emitter 424 d. As tracheal tube is moved into thepatient's respiratory system 11 d without benefit of the guide rod 50 d,the output from the emitter connected to the leading end portion of thetracheal tube would be detected by the sensor units 440. The output fromthe sensor units 440 would indicate the position of the leading endportion of the tracheal tube relative to the patient's respiratorysystem 11 d.

In the embodiment of the invention illustrated in FIGS. 13-16, magnetshave been utilized as emitter units. The magnets which form the emitterportion 424 of the sensor assembly 420 are permanent magnets formed of astrongly magnetizable material such as cobalt or neodymium. Of course,other know magnetizable materials having saturation magnetizationvalues, such as cerium, praseodymium and or samarium with cobalt and/orother materials could be used. Alternatively, the magnets in the emitterportion 424 (FIG. 14) and 424 d (FIG. 15) could be electromagnets.

The detector portion 426 (FIG. 13) and 426 d (FIG. 16) of the sensorassemblies 420 and 420 d may be any known device which respond tochanges in the strength and/or direction of a magnet field. For example,the detector portions 426 include one or more Hall effect devices and/orone or more magnetoresistors.

Although the emitter portions 424 and 424 d of the sensor assemblies 420and 420 d have been described herein as emitting magnetic fields, it iscontemplated that the emitter portions 424 and 424 d could have outputsother than a magnetic field. For example, the emitter portions 424and/or 424 d (FIGS. 14 and 15) could be miniaturized radio frequencydevices. Thus, the emitter portions of the sensor assemblies could beformed by radio signal transmitters having miniaturized radio circuitrywhich provide a radio frequency output signal. If a radio frequencytransmitter is utilized in the emitter portion 424 or 424 d of thesensor assemblies, the sensor portion 426 or 426 d would be a radiofrequency receiver. The radio frequency receiver could include areceiving antenna which receives radio frequency signals. The field ofthe antenna may be controlled by appropriate placement, orientation,and/or configuration of the antenna.

Alternatively, the emitter portions 424 and 424 d could emit ultrasonicenergy. The sensor portion 426 or 426 d would respond to ultrasonicenergy.

Embodiment of FIGS. 17 and 18

In the embodiment of the invention illustrated in FIGS. 13 and 14, thesensor assembly 420 includes a detector portion 426 which is disposed onthe leading end portion 52 c of the guide rod 50 c and responds to amagnetic field. The operator of the positioning apparatus 56 c isinformed, by a display system connected with the computer 438, of theposition of the leading end portion 52 c of the guide rod 50 c relativeto the patient's respiratory system 11 c. In the embodiment of theinvention illustrated in FIGS. 17 an 18, the leading end portion of theguide rod is steerable to enable the other operator to alter the courseof movement of the leading end portion of the guide rod to maintain theleading end portion of the guide rod on a desired insertion path intothe patient's respiratory system. Since the embodiment of the inventionillustrated in FIGS. 17 and 18 is generally similar in the embodiment ofthe invention illustrated in FIGS. 13-16, similar numerals will beutilized to designate similar components, the suffix letter “e” beingassociated with the numerals of FIGS. 17 and 18 to avoid confusion.

The embodiment of the invention illustrated in FIGS. 17 and 18 isutilized with a positioning apparatus having the same construction asthe positioning apparatus of FIGS. 1, 2, and 13-16. However, theembodiment of the invention illustrated in FIGS. 17 and 18 could be usedwith the positioning apparatus 256 and/or 256 a of FIGS. 4-11 ifdesired. The guide rod 50 e of FIGS. 17 and 18 is provided with asteering apparatus 460. The steering apparatus 460 is operable to changethe course of movement of the leading end portion 52 e of the flexibleguide rod 50 e as the guide rod moves along the insertion path into thepatient's respiratory system.

The steering apparatus 460 applies force against body tissue in thepatient's respiratory system to deflect the leading end portion 52 e ofthe flexible guide rod 50 e away from an undesired course of movement.For example, when the leading end portion of the guide rod 50 e isapproaching a junction between the patient's esophagus 26 (FIG. 1) andtrachea 28, the steering apparatus 460 (FIGS. 17 and 18) may beactivated to deflect the leading end portion 52 e of the guide rod 50 eaway from the entrance to the patient's esophagus. Similarly, when theleading end portion 52 e of the guide rod 50 e is approaching the larynx30, the steering apparatus 460 may be activated to align the leading endportion 52 e of the guide rod with an opening between vocal chords inthe patient's larynx.

In the illustrated embodiment of the invention, the steering apparatus460 includes a plurality of expandable elements 464, 466 and 468 (FIG.18). Although three expandable elements 464-468 have been illustrated asbeing disposed in a circular array about the leading end portion 52 e ofthe guide rod 50 e, a greater or lesser number of expandable elementscould be provided in association with the leading end portion of theguide rod if desired.

The expandable elements 464, 466 and 468 are individually activatable sothat one, two or all three of the expandable elements can be expanded.For example, just the expandable element 464 (FIG. 18) may be expandedto apply force against the leading end portion 52 e of the guide rod 50e to move the guide rod downward (as viewed in FIG. 18) relative to apath of movement of the guide rod through the patient's respiratorysystem. Alternatively, the expandable elements 466 and 468 may beexpanded at the same time to deflect the leading end portion 52 e of theguide rod 50 e upward (as viewed in FIG. 18). It is believed that it maybe desired to center the leading end portion 52 e of the guide rod 50 ein a passage in the patient's respiratory system. When this is to bedone, all three expandable elements 464, 466, and 468 would be expanded.

In the illustrated embodiment of the invention, the expandable elements464, 466 and 468 are balloons or bladders which are expanded under theinfluence of fluid pressure, that is, under the influence of either agas or a liquid. To enable the expandable elements 464, 466 and 468 tobe individually expanded, conduits 472, 474 and 476 are each connectedin fluid communication with one of the expandable elements 464, 466 or468. For example, when the expandable element 464 is to expanded, fluidunder pressure is connected through the conduit 472 to the expandableelement 464. Similarly, when the expandable element 466 is to expanded,fluid under pressure is connected through the conduit 474 to theexpandable element 466. Finally, when the expandable element 468 is tobe expanded, fluid under pressure is connect through the conduit 476 tothe expandable element 468.

After one or more of the expandable element 464-468 have been expandedto steer the leading end portion 52 e of the guide rod 50 e, theexpandable elements 464, 466 and/or 468 are contracted. This may beaccomplished by connecting the conduits 472, 474 and/or 476 with asource of suction or low pressure. The expandable elements 464, 466 and468 are contracted under the influence of their own natural resilience.If desired, springs could be provided in association with the expandableelements to contract the expandable elements 464-468.

The contracted expandable elements 464, 466 and 468 are disposed inengagement with an outer side surface of the leading end portion 52 e ofthe guide rod 50 e. If desired, recesses could be provided in theleading end portion of the guide rod 50 e to receive each of theexpandable elements 464, 466 and 468 when the expandable elements are intheir contracted condition.

It is believed that it will be preferred to form the expandable elements464, 466 and 468 of a resiliently stretchable polymeric material so thatthe expandable elements can be expanded, under the influence of fluidpressure, by stretching the material of the expandable elements. Whenthe expandable elements are to be deflated, the resiliently stretchedelastomeric material of the expandable elements 464-468 will tend toforce fluid out of the expandable elements and cause them to return totheir contracted conditions. When the retracted, the expandable elements464, 466 and 468 are disposed in either separate recesses or a singleannular recess which extends around the leading end portion of the guiderod 50 e. The contracted expandable elements do not project outward fromthe outer side surface of the guide rod 50 e. Alternatively, thecontracted expandable elements 464-468 could be contracted, under theinfluence of their own natural resilience, into tight abuttingengagement with the outer side surface of the guide rod 50 e.

It is contemplated that the conduits 472, 474 and 476 and expandableelements 464, 466 and 468 may be formed in a manner similar to thatdisposed in U.S. patent application Ser. No. 08/470,142 filed Jun. 6,1995 by Peter M. Bonutti et al. and entitled Method Of Using ExpandableCannula. The disclosure of the aforementioned application Ser. No.08/470,142 is hereby incorporated herein in its entirety by thisreference thereto. Alternatively, the expandable elements 464, 466 and468 could be formed in manners similar to that disclosed in U.S. Pat.No. 3,833,003 and/or 5,197,971.

Although the illustrated expandable elements 464-468 are expanded underthe influence of fluid pressure, they could be expanded in a differentmanner if desired. For example, mechanical actuators could be provided.The mechanical actuators may be utilized to move members which are notballoons.

In order to enable an operator of the positioning apparatus to determinethe location of the leading end portion 52 e of the guide rod 50 erelative to the patient's respiratory system, a sensor assembly, similarto the sensor assembly 420 of FIGS. 13 and 14, is utilized inassociation with the steering apparatus 460. In the embodiment of theinvention illustrated in FIG. 17, the detector portion 426 e of thesensor assembly includes a detector 480 which responds to an output froman emitter portion of the sensor assembly. The detector 480 is enclosedby a soft dome or cap 482 which forms part of the leading end portion 52e of the guide rod 50 e. The dome or cap 482 cushions engagement of theleading end portion 52 e of the guide rod 50 e with body tissue alongthe patient's respiratory system. In addition, the dome 482 protects thedetector portion 426 e.

The detector 480 may be a Hall effect device which cooperates withemitters, which are magnets, in the manner described in conjunction withFIGS. 13 and 14. Alternatively, the detector 480 may respond to radiofrequency radiation. If desired, the detector 480 could be constructedso as to respond to ultrasonic energy. Rather than providing a detector480 on the leading end portion 52 e of the guide rod 50 e, an emittercould be provided in the manner described in conjunction with FIGS. 15and 16.

The detector portion 426 e (FIG. 17) is connected with a computer,similar to the computer 438 of FIG. 13, by a lead 486 (FIG. 17). Theoutput from the computer indicates to an operator the position of theleading end portion 52 e of the guide rod 50 e relative to the patient'srespiratory system. The output of the computer will also indicate to theoperator when the leading end portion 52 e of the guide rod 50 e maydeviate from the intended course of insertion of the guide rod into thepatient's respiratory system.

When the output from the computer indicates that the leading end portionof the guide rod may not move along the intended insertion path, theoperator may initiate expansion of one or more of the expandableelements 464-468. The expandable elements will apply force against thepatient's body tissue and against the leading end portion 52 e of theguide rod 50 e to deflect the guide rod in such a manner as to maintainthe guide rod on its intended insertion path into the patient'srespiratory system.

As was previously described in conjunction with the embodiments of theinvention illustrated in FIGS. 13-16, a visual display system,illustrative of the patient's respiratory system, may be connected withthe computer which receives the output from a sensor assembly 420 or 420d. By viewing an illustration depicting the location and path ofmovement of the leading end portion 52 e of the flexible guide rod 50 e,an operator will know when to expand one or more of the expandableelements 464, 466 and 468.

It is contemplated that the steering apparatus 460 and position sensingassembly may be used with devices for purposes other than trachealintubination. For example, the steering apparatus 460 and positionsensing assembly used with the guide rod 50 e of FIG. 17 could be usedin association with a device which is used to position medicant at aselected location in a patient's body. It is also contemplated that thesteering apparatus 460 and position sensing assembly could be used inconjunction with endoscopic, arthroscopic, or fiber optic surgery.

Embodiment of FIG. 19.

In the embodiment of the invention illustrated in FIGS. 17 and 18, thesteering apparatus 460 is disclosed in conjunction with the guide rod 50e which is used with a sensor assembly, corresponding with the sensorassembly 420 of FIG. 13, in which the detector portion is disposed onthe leading end portion 52 e of the guide rod. In the embodiment of theinvention illustrated in FIG. 19, the steering apparatus is disposed inassociation with a guide rod having an emitter portion of a sensorassembly disposed on the leading end portion of the guide rod in themanner illustrated in FIGS. 15 and 16. Since the embodiment of theinvention illustrated in FIG. 19 is generally similar to the embodimentsof the invention illustrated in FIG. 13-18, similar numerals will beutilized to designate similar components, the suffix letter “f” beingassociated with the numerals of FIG. 19 in order to avoid confusion.

A guide rod 50 f has a leading end portion 52 f. The guide rod 50 f isused with a positioning apparatus similar to the positioning apparatus56 d of FIG. 15. The flexible guide rod 50 f (FIG. 19) is associatedwith a sensor assembly corresponding to the sensor assembly 420 d ofFIG. 15. Thus, the guide rod 50 f has an emitter portion 424 f (FIG. 19)which is connected with the leading end portion 52 f of the guide rod.The output from the emitter portion 424 f is detected by suitabledetectors disposed adjacent to the exterior surface of the patient'sneck and to the patient's Adam's apple, in the manner illustratedschematically in FIG. 16.

In the embodiment of the invention illustrated in FIG. 19, the emitterportion 424 f includes a light source 490. The light source 490 isconnected with source of electrical energy by a lead 492. The lightsource 490 has been illustrated schematically in FIG. 19 as being anincandescent light source. However, it may be preferred to provide asolid state device as a light source 490. For example, one or more lightemitting diodes could be disposed on the leading end portion 52 f of theguide rod 50 f to function as a light source.

It is contemplated that the electrical energy conducted over the lead492 to the light source 490 may be varied as the light source movesalong the insertion path into the patient's respiratory system. Forexample, if the light source is pulsed from a maximum light emissionlevel to a minimum light emission level, detection of the location ofthe leading end portion 52 f of the guide rod 50 f may be facilitated.

The light source 490 may be detected by suitable photo optic devices,such as photo cells or may be visually detected by the operator of theapparatus associated with the guide rod 50 f. When the light source 490is to be detected by the operator of the positioning apparatus, that is,when the operator is to function as the detector portion of the sensorassembly, it is believed that pulsing the light source will facilitatevisual detection of the light source by the operator. It should beunderstood that both photo electric detection apparatus and visualdetection by the operator could be utilized to locate the position ofthe leading end portion 52 f of the guide rod 50 f as the guide rod ismoved into the patient's respiratory system.

A steering apparatus 460 f (FIG. 19) is connected with the leading endportion 52 f of the guide rod 50 f. The steering apparatus 460 fincludes a plurality of expandable elements 464 f and 466 f. Althoughonly two expandable elements 464 f and 466 f have been illustratedschematically in FIG. 19, it should be understood that a thirdexpandable element, corresponding to the expandable element 468 of FIG.18, is connected with the leading end portion 52 f of the guide rod 50f. The expandable elements are connected with a source of inflationfluid by conduits 472 f, 474 f and 476 f.

When one or more of the expandable elements connected with the leadingend portion 52 f (FIG. 19) of the guide rod 50 f are to be expanded,fluid under pressure is conducted to the expandable elements. Forexample, when the expandable element 464 f is to be operated from acontracted condition to an expanded condition, fluid under pressure,which may be either a gas or liquid, is conducted through the conduit472 f to the expandable element 464 f. As the expandable element 464 fis operated from a contracted condition to an expanded condition of theinfluence of fluid pressure, the expandable element applies forceagainst the adjacent body tissues in the patient's respiratory systemand applies force against the leading end portion 52 f of the guide rod50 f. The force applied against the leading end portion 52 f of theguide rod 50 f deflects the leading end portion 52 f of the guide rod 50f downward (as used in FIG. 19) to maintain the guide rod on theintended path of insertion into the patient's respiratory system. Theoutput from the emitter portion 424 f of the sensor assembly enables theoperator to determine when it is necessary to expand one or more of theexpandable elements and to determine which of the expandable elements tobe expanded.

In the embodiment of the invention illustrated in FIG. 19, the emitteron the leading end portion of the guide rod 50 f is a light source 490.However, a different type of emitter could be provided if desired. Forexample, the emitter could be a magnet which cooperates with detectorsin the manner previously described in conjunction with FIGS. 15 and 16.Alternatively, the emitter could be a miniaturized radio frequencytransmitter.

Embodiment of FIG. 20

In the embodiment of the invention illustrated in FIGS. 13 through 19,sensor assemblies have been illustrated as being associated with a guiderod of a positioning apparatus. In the embodiment of the inventionillustrated in FIG. 12, fiber optics are utilized in association with alight source to enable an operator to view images of body tissueimmediately ahead of the leading end portion of a guide rod 50 b. In theembodiment of the invention illustrated in FIG. 20, a light source andfiber optics are associated with a tracheal tube to enable an operatorto view images of body tissue immediately ahead of a leading end portionof the tracheal tube during of insertion of the tracheal tube into apatient's respiratory system. Since the embodiment of the inventionillustrated in FIG. 20 is generally similar to the embodiments of theinvention illustrated in FIGS. 1, 2 and 12, similar numerals will beutilized to designate similar components, the suffix letter “g” beingassociated with the numerals of FIG. 20 to avoid confusion.

A flexible tracheal tube 38 g (FIG. 20) has a leading end portion 500. Alight source 400 g is disposed on the leading end portion 500 of thetracheal tube 38 g. The light source 400 g is connected with a source ofelectrical energy by leads 504 and 506. When the tracheal tube 38 g ismoving along an insertion path into a patient's respiratory system, thelight source 400 g illuminates body tissue immediately ahead of theleading end portion 500 of the tracheal tube 38 g.

In the embodiment of the invention illustrated in FIG. 20, the lightsource 400 g is mounted on the leading end portion of the tracheal tube38 g. However, it is contemplated that the light source could bedisposed at a location remote from the leading end portion 500 of thetracheal tube 38 g and illumination transmitted from the light source tothe leading end portion of the tracheal tube through a fiber optic tube,corresponding to the fiber optic tube 402 of FIG. 12. Of course, aplurality of fiber optic tubes could be utilized if desired.

The light source 400 g has been illustrated schematically in FIG. 20 asbeing an incandescent light source. However, it is contemplated that oneor more solid state devices, such as light emitting diodes, could formthe light source 400 g if desired. A plurality of light sources 400 gcould be disposed in a circular array on the leading end portion 500 ofthe tracheal tube 38 g.

A prismatic lens 510 is also mounted on the leading end portion 500 ofthe tracheal tube 38 g. The lens 510 is enclosed by a transparent dome512 which is connected with the leading end portion 500 of the trachealtube 38 g. Light is transmitted from the lens 510 through a fiber optictube 408 g to the eye of a viewer or to a display unit associated with acomputer. The lens 510 is oriented so that images of body tissueimmediately ahead of the leading end portion 500 of the tracheal tube 38g are transmitted through the fiber optic tube 408 g. Although only asingle light source 400 g and single lens 510 have been illustratedschematically in FIG. 20, it should be understood that a plurality oflight sources and/or a plurality of lenses may be mounted on the leadingend portion 500 of the tracheal tube 38 g.

The flexible tracheal tube 38 g may be utilized in association with thepositioning apparatus 56 of FIGS. 1 and 2 or with the positioningapparatus 256 of FIG. 4. Alternatively, the tracheal tube 38 g may beutilized by itself, that is without a positioning apparatus. If thetracheal tube 38 g is utilized with a positioning apparatus similar tothe positioning apparatus 56 or 256, the tracheal tube may be movedalong a guide rod similar to the guide rod 50 or the guide rod 250 asthe tracheal tube is moved into a patient's respiratory system. However,the tracheal tube may be moved along a guide rod into a patient'srespiratory system without utilizing a positioning apparatus, similar tothe positioning apparatus 56 or 256 of FIGS. 1 and 4.

The tracheal tube 38 g may be moved along an insertion path into apatient's respiratory system without benefit of a guide rod. If desired,a steering apparatus, corresponding to the steering apparatus 460 and460 f of FIG. 17-19, may be associated with the leading end portion ofthe tracheal tube 38 g. Thus, expandable elements, corresponding to theexpandable elements 464, 466 and 468 of FIG. 18 may be connected withthe leading end portion 500 of the tracheal tube 38 g. The expandableelements connected with the leading end portion 500 of the tracheal tube38 g may be connected in fluid communication with a source of fluidunder pressure through conduits disposed in the side wall of thetracheal tube. Since images of body tissue immediately ahead of theleading end portion of the tracheal tube are transmitted through thefiber optic tube 408 g, an operator who is positioning the tracheal tuberelative to a patient's respiratory system will be able to view imagesof the body tissue and, from these images, be able to determine when toactivate one or more expandable elements of a steering apparatusconnected with the leading end portion 500 of the tracheal tube 38 g.

Embodiment of FIG. 21

In the embodiment of the invention illustrated in FIG. 20, images ofpatient's body tissue are transmitted from the leading end portion ofthe tracheal tube for viewing by an operator who is inserting thetracheal tube into the respiratory system of a patient. In theembodiment of the invention illustrated in FIG. 21, the tracheal tube isassociated with a sensor assembly having the same construction as thesensor assembly 420 of FIGS. 13 and 14. Since the embodiment of theinvention illustrated in FIG. 21 is generally similar to the embodimentof the invention illustrated in FIGS. 13, 14 and 20, similar numeralswill be utilized to designate similar components, the suffix letter “h”being associated with the numerals of FIG. 21 to avoid confusion.

A tracheal tube 38 h (FIG. 21) has a leading end portion 500 h. Adetector portion 426 h is provided on the leading end portion 500 h ofthe tracheal tube 38 h. The detector portion 426 h cooperates with anemitter portion of a sensor assembly having the same construction as theemitter portion 424 (FIG. 14) of the sensor assembly 420.

The tracheal tube 38 h includes a plurality of magnetic flux sensorunits 440 h which respond to variations in a magnetic flux field inwhich the sensor units are exposed. In the illustrated embodiment of theinvention, the sensor units 440 h are Hall effect devices. However, thesensor units 440 h could be other known types of devices which respondto a magnetic flux field.

The sensors 440 h are connected with a computer, similar to the computer438 of FIG. 13, by a plurality of leads 442 h. The computer to which theleads 442 h are connected has a display unit which displays an image ofa typical respiratory system. The display indicates the position of theleading end portion 500 h of the tracheal tube 38 h relative to thepatient's respiratory system.

In addition, the computer display may also indicate the position of aguide rod, corresponding to the guide rod 50 c of FIG. 13, relative tothe patient's respiratory system. Therefore, the computer display showsthe position of the leading end portion 500 h of the tracheal tube 38 hrelative to the leading end portion 52 c (FIG. 13) of the guide rod 50c. Although the tracheal tube 38 h may advantageously be utilized inassociation with a guide rod, similar to the guide rod 50 c, it iscontemplated that the tracheal tube 50 h could be utilized by itselfwithout an associated guide rod. Of course, if the tracheal tube 38 hwas utilized by itself without a guide rod similar to the guide rod 50 cof FIG. 13, the output from the computer would indicated the position ofthe leading end portion 50 h of the tracheal tube 38 h relative to thepatient's respiratory system and would not indicate the location of theguide rod.

It is contemplated that a steering apparatus similar to the steeringapparatus 460 of FIG. 17 may be utilized with the tracheal tube 38 h(FIG. 21). A plurality of expandable elements, corresponding to theexpandable elements 464, 466 and 468 of FIG. 18, would be connected withthe leading end portion 50 h of the tracheal tube 38 h. The cooperationbetween the Hall effect devices forming the sensor units 440 h and themagnets of an associated detector portion of a sensor assembly wouldenable an operator inserting the tracheal tube 38 h into a patient'srespiratory system to determine when one or more of the expandableelements should be expanded to steer the leading end portion 500 h ofthe tracheal tube 38 h.

Embodiment of FIG. 22

In the embodiment of the invention illustrated in FIG. 19, a lightsource 490 and steering apparatus 460 f is associated with the leadingend portion 52 f of a guide rod 50 f. In the embodiment of the inventionillustrated in FIG. 22, a plurality of light sources and a steeringapparatus are associated with the leading end portion of a trachealtube. Since the embodiment of the invention illustrated in FIG. 22 isgenerally similar to the embodiments of the invention illustrated inFIGS. 19-21, similar numerals will be utilized to designate similarcomponents, the suffix letter “j” being associated with the numerals ofFIG. 22 to avoid confusion.

A tracheal tube 38 j has a leading end portion 500 j. A plurality oflight sources 490 j are mounted on the leading end portion 500 j of thetracheal tube 38 j. The light sources 490 j are energized by electricalenergy connected over leads 492 j. Although the light sources 490 j havebeen indicated schematically in FIG. 22 as being incandescent lightsources, it is contemplated that solid state devices, such as lightemitting diodes, could be utilized as the light sources if desired.

The steering apparatus 460 j is mounted on the leading end portion 500 jof the tracheal tube 38 j. The steering apparatus 460 j includes aplurality of expandable elements 464 j and 466 j. Although only twoexpandable elements 464 j and 466 j have been illustrated schematicallyin FIG. 22, it should be understood that there are three expandableelements connected with the leading end portion 500 j of the trachealtube 38 j. The expandable elements are disposed in an array around theend of the tracheal tube in much the same manner as illustratedschematically in FIG. 18 in association with the guide rod 50 e.

The expandable elements 464 j and 466 j are connected with conduits 472j and 474 j. The conduits 472 j and 474 j are formed in the side wall ofthe tracheal tube 38 j in the manner indicated schematically in FIG. 22.Of course, a third conduit is provided to conduct fluid to and from athird expandable element on the end portion 500 j of the tracheal tube38 j. It should be understood that the conduits 472 j and 474 j could beformed separately from the tracheal tube 38 j if desired.

When the steering apparatus 460 j is to be utilized to change the courseof movement of the leading end portion 500 j of the tracheal tube 38 jrelative to a patient's respiratory system, one or more of theexpandable elements in the steering apparatus 460 j is inflated underthe influence of fluid pressure conducted through an associated conduit.For example, if the expandable element 464 j is to be operated from acontracted condition to the expanded condition illustrated schematicallyin FIG. 22, fluid pressure is connected through the conduit 472 j. Asthe expandable element 464 j expands, forces are applied against tissuein the patient's respiratory system by the expandable element 464 j. Atthe same time, the expandable element 464 j is effective to apply forceagainst the leading end portion 500 j of the tracheal tube 38 j todeflect the tracheal tube downward (as viewed in FIG. 22.

It is contemplated that the tracheal tube 38 j may be utilized inassociation with a guide rod, such as the guide rod 50 f of FIG. 19 orthe guide rod 50 of FIG. 1. However, if desired, the tracheal tube 38 jcould be inserted into a patient's respiratory system without thebenefit of a guide rod.

When the tracheal tube 38 j is to be inserted into a patient'srespiratory system, either with or without a guide rod, the lightsources 490 j are energized. Energization of the light sources 490 jresults in the emission of light which can be detected by photo cells orsimilar devices positioned adjacent to the outside of the patient'sneck. If desired, the photo cells could be eliminated and an operatorcould visually locate the leading end portion 50 j of the tracheal tube38 j by viewing the illumination conducted through the patient's bodytissues to the surface of the patient's neck. It is contemplated that anoperator will, in all probability, locate the leading end portion 500 jof the tracheal tube 38 j by a combination of the output from photodetectors and visually viewing the patient's neck. If desired, the lightsources 490 can be pulsed to provide a variation in the illuminationfrom the light sources to facilitate visual locating of the leading endportion of the tracheal tube 38 j by an operator.

When the inflatable elements 464 j and/or 466 j are to be operated fromthe expanded condition illustrated in FIG. 22 to a contracted condition,the conduits 472 j and 474 j may be exhausted to atmosphere. It isbelieved that it may be preferred to connect the conduits 472 j and 474j with a source of low pressure or suction so that fluid is drawn out ofthe expandable elements.

As the fluid pressure in the expandable elements 460 j and 466 j isreduced, the natural resilience of the expandable elements causes themto contract tightly against the leading end portion 500 j of thetracheal tube 38 j. If desired, a plurality of recesses may be providedin the leading end portion 500 j of the tracheal tube 38 j to receivethe expandable elements 464 j and 466 j. Of course, if additionalexpandable elements are associated with the leading end portion 500 j ofthe tracheal tube 38 j, additional recesses would be provided to receivethese expandable elements when they are contracted.

Various types of emitters and detectors have been illustrated in FIGS.20, 21 and 22 in association with the tracheal tube 38 j. It should beunderstood that any of the emitters or detector systems previouslydescribed in association with a guide rod may be utilized in associationwith a tracheal tube. For example, a radio frequency transmitter and areceiver may be utilized as the emitter portion and the sensor portionof a sensor assembly which is utilized to detect the location of theleading end portion of a tracheal tube relative to a patient'srespiratory system.

Although it is believed that it will probably be preferred to utilize asteering apparatus, similar to the steering apparatus 460 j inassociation with the tracheal tube, the steering apparatus could beomitted if desired.

Positioning Apparatus—General—Mode of Operation

The general mode operation of the positioning apparatus 56 of FIG. 1 isillustrated schematically in FIG. 23. As was previously explained, thepositioning apparatus 56 includes an arcuate member 108. The arcuatemember 108 has a center of curvature indicated at 600 in FIG. 23.

The body section 86 of the positioning apparatus 56 has a central axiswhich extends through the center 600. The positioning section 96 isconnected with an end of the body section 86 which is disposed closestto the center 600 of curvature of the arcuate member 108. The indicia124 (FIG. 1) on the body section 86 is effective to indicate the lengthof the body section 86.

The guide rod 50 also has a central axis which extends through thecenter 600 of curvature of the arcuate section 108. The indicia 142(FIG. 1) on the guide rod 50 indicates the distance from the leading endportion 52 of the guide rod 50 from the arcuate member 108. The guiderod 50 and body section 86 of the positioning apparatus 56 are bothradiuses from the center 600 of curvature of the arcuate member. Whenthe indicia 142 (FIG. 1) indicates that the guide rod 50 (FIG. 23)extends from the arcuate member 108 for the same distance as the bodysection 86, the leading end portion 52 of the guide rod 50 is alignedwith the positioning apparatus 96. Since the positioning apparatus 96 isaccurately located relative to the patient's respiratory system 11(FIG. 1) by engagement with the patient's Adam's apple 34, the positionof the leading end portion 52 of the guide rod relative to the patient'slarynx 30 is known when the leading end portion 52 of the guide rod 50is aligned with positioning apparatus 96.

An alternative embodiment of the positioning apparatus 56 is illustratedin FIG. 24. Since the embodiment of the positioning apparatusillustrated in FIG. 24 is generally similar to the embodiment of thepositioning apparatus 56 illustrated in FIGS. 1 and 23, similar numeralswill be utilized to indicate similar components, the suffix letter “k”being associated with the components of FIG. 24 to avoid confusion.

A positioning apparatus 56 k includes a body section 86 k. A positioningsection 96 k is connected with an end portion of the body section 86 k.The positioning section 96 k engages the patient's Adam's apple, in themanner previously described in conjunction with the apparatus 56 of FIG.1.

In the embodiment of the invention illustrated in FIG. 24, a member 108k is fixedly connected with the body section 86 and extends at a knownangle, indicated at 604 in FIG. 24. A guide section 114 k is disposed atan end of the member 108 k opposite from the connection 606 with thebody section 86 k. The guide rod section 114 k guides movement of aguide rod 50 k along a path which extends through a center 600 k.

The center 600 k is disposed at the intersection of a longitudinalcentral axis of the body section 86 k and a longitudinal central axis ofthe guide rod 50 k. An angle, indicated at 610 in FIG. 24, formedbetween the longitudinal central axis of the body section 86 k and theguide rod 50 k is known. The distance from the positioning section 96 kto the connection 606 between the body section 86 k and member 108 k isknown. The angles 604 and 610 are known. The length of the member 108 isalso known. Therefore the distance which the guide rod 50 k must extendfrom the guide section 114 k to have the leading end portion 52 k of theguide rod aligned with the positioning section 96 k can readily bedetermined by trigonometric functions.

It should be understood that features of any one embodiment of theinvention may be used with features of other embodiments of theinvention. For example, the positioning apparatus 256 of FIGS. 4-10could have the same construction as the positioning apparatus 56 ofFIGS. 1-3. Similarly, the magnet 260 of FIG. 4 could be used with theembodiment of the invention illustrated in FIGS. 1-3. The sensorassemblies 420 could be used with either the positioning apparatus 56 ofFIG. 1 or the positioning apparatus 256 of FIGS. 4-10. Othercombinations of features of the invention will undoubtedly be utilized.

Embodiment of FIGS. 25 and 26

In the embodiments of the invention illustrated in FIGS. 1-24, thepositioning apparatus 56 has a positioning section 96 which engages thepatient's Adam's apple 34. In the embodiment of the inventionillustrated in FIGS. 25 and 26, the positioning apparatus engages aplurality of locations on the patient's neck. Since the embodiment ofthe invention illustrated in FIGS. 25 and 26 is generally similar to theembodiments of the invention illustrated in FIGS. 1-24, similar numeralswill be utilized to designate similar components, the suffix letter “m”being associated with the numerals of FIGS. 25 and 26 to avoidconfusion.

A positioning apparatus 56 m is utilized to position a guide rod 50 mcorresponding to the guide rod 50 of FIG. 1, relative to a patient'strachea 28 m during insertion of the guide rod into the patient'strachea. In addition, the positioning apparatus 56 m provides anindication of the distance which the guide rod 50 m is to be moved intothe patient's trachea 28 m. The positioning apparatus 56 m includes abase section 78 m which is connected with an arcuate upper section,corresponding to the arcuate upper section 80 of FIG. 1. The basesection 78 m includes a tubular cylindrical body section 86 b. The basesection 78 m also includes a positioning section 96 m. The positioningsection 96 m locates the positioning apparatus 56 m relative to thepatient's Adam's apple 34 m.

In accordance with a feature of the embodiment of the inventionillustrated in FIGS. 25 and 26, the positioning section 96 includes apair of positioning fingers 622 and 624 which engage the neck 16 m ofthe patient at locations disposed on laterally opposite sides of theAdam's apple 34 m. Thus, the positioning finger 622 is provided with arelatively soft resilient spherical end portion 628 which is pressedagainst the patient's neck 16 m at a location adjacent to the left (asviewed in FIG. 26) side of the patient's Adam's apple. Similarly, thepositioning finger 624 has a soft resilient spherical end portion 630which is pressed against the patient's neck 16 m at a location adjacentto the right (as viewed in FIG. 26) side of the patient's Adam's apple34 m. The positioning fingers 622 and 624 cooperate with the patient'sAdam's apple 34 m to locate the positioning section 96 m laterallyrelative to the patient's Adam's apple 34 m.

In the embodiment of the positioning section 96 m illustrated in FIGS.25 and 26, the positioning section is provided with a straight centerpositioning finger 634 which is formed as a continuation of the tubularcylindrical body section 86 m of the positioning apparatus 56 m. Thus,the body section 86 m and center positioning finger 634 are integrallyformed as one piece. The center positioning finger 634 has a softresilient spherical end portion 636 which is pressed against thepatient's Adam's apple 34 m at the center of the patient's Adam's apple.

Force may be applied against the body section 86 m of the positioningapparatus 56 m and transmitted to the patient's neck 16 m to straightenthe trachea of the patient. Thus, a slight bend in the trachea can beminimized by the manual application of a relatively small force to thepositioning apparatus 56 m. This force is transmitted through the endportions 628 and 630 of the positioning fingers 622 and 624 to thepatient's neck to straighten the patient's neck. In addition, a portionof the force will be transmitted through the center positioning finger634 directly to the patient's Adam's apple 34 m.

The position of the end portions 628 and 630 of the positioning fingers622 and 624 relative to the body section 86 m of the base section 78 mof the positioning apparatus 56 m (FIG. 25) can be varied. Thus, thepositioning fingers 622 and 624 are fixedly connected to a slide block640 which is axially movable along the body section 86 m. The bodysection 86 m extends through a cylindrical central opening in the slideblock 640. A set screw 642 (FIG. 25) having manually engagable wings orflanges can be tightened to hold the positioning fingers 622 and 624 ina desired position relative to the body section 86 m of the positioningapparatus 56 m. This enables the length of the center positioning finger634 to be adjusted. By adjusting the length of the center finger 634, arelatively small amount of force can be transmitted through the centerfinger 634 directly to the patient's Adam's apple 34 m and substantiallylarger forces can be transmitted through the positioning fingers 622 and624 to the patient's neck 16 m to locations disposed on opposite sidesof the patient's Adam's apple 34 m.

It should be understood that the positioning section 96 m of FIGS. 25and 26 can be utilized in any of the positioning apparatus disclosed inFIGS. 1 through 24 herein. When the positioning section 96 m is to beassociated with the positioning apparatus 56 c of FIG. 13, the emitterunits 430 (FIG. 14) could be mounted on or adjacent to the end portions628, 630 and 636 (FIGS. 25 and 26) of the positioning fingers 622, 624and 634. Similarly, when the positioning section 96 m is utilized inassociation with the positioning apparatus 56 d of FIGS. 15 and 16, thesensor units 440 may be disposed adjacent to and connected with the endportions 628, 630 and 636 (FIG. 25) of the positioning fingers 622, 624and 634.

It should be understood that the positioning apparatus 56 m (FIGS. 25and 26) may be associated with guide rods having the construction of theguide rod 50 of FIG. 1, the guide rod 250 of FIGS. 4 and 8, the guiderod 50 e of FIGS. 17 and 18, or the guide rod 50 f of FIG. 19. It shouldalso be understood that the positioning apparatus 56 m may be associatedwith a tracheal tube having the construction of any one of the trachealtubes 38 (FIG. 2), 238 (FIGS. 9 and 10), 38 g (FIG. 20), 38 h (FIG. 21),or 38 j (FIG. 22).

Embodiment of FIGS. 27 and 28

In the embodiment of the invention illustrated in FIGS. 25 and 26, thepositioning fingers 622 and 624 are fixedly connected with the bodysection 86 m of the positioning apparatus 56 m by the slide block 640while the positioning fingers 634 is integrally formed as one piece withthe body section 36 m. In the embodiment of the invention illustrated inFIGS. 27 and 28, the positioning fingers are movable relative to thebody section of the positioning apparatus. Since the embodiment of theinvention illustrated in FIGS. 27 and 28 is generally similar to theembodiments of the invention illustrated in FIGS. 1-26, similar numeralswill be utilized to designate similar components, the suffix letter “r”being associated with the numerals of FIGS. 27 and 28 to avoidconfusion.

A positioning apparatus 56 r positions a guide rod, corresponding to theguide rod 50 of FIG. 1, relative to a patient's trachea during insertionof the guide rod into the patient's trachea. In addition, thepositioning apparatus 56 r provides an indication of the distance whichthe guide rod is to be moved into the patient's trachea. Although only aportion of the positioning apparatus 56 r is illustrated in FIGS. 27 and28, it should be understood that the positioning apparatus may have thesame general construction as the positioning apparatus of any one of theembodiments illustrated in FIGS. 1-19.

The positioning apparatus 56 r includes a base section 78 r which isconnected with an arcuate upper section corresponding to the arcuateupper section 80 of FIG. 1. The upper section of the positioningapparatus 56 r guides movement of a guide rod, corresponding to theguide rod 50 of FIG. 1, during insertion of the guide rod into thepatient's trachea.

In accordance with a feature of the present invention, a positioningsection 96 r is connected with the base section 78 r. The positioningsection 96 r locates the positioning apparatus 56 r relative to thepatient's Adam's apple 34 r (FIG. 28). The positioning section 96 r isconnected with an end of a body section 86 r of the positioningapparatus 56 r by a universal pivot connection 652. The pivot connection652 allows the orientation of the base section 78 r of the positioningapparatus 56 r to be changed in any direction relative to thepositioning section 96 r. Thus, the body section 86 r of the positioningapparatus 56 r can be raised or lowered (as viewed in FIG. 27) orpivoted to the left or right (as viewed in FIG. 28.

The positioning section 96 r includes a plurality of positioning fingers622 r, 624 r and 634 r. The positioning fingers 622 r, 624 r and 634 rare provided with soft resilient spherical end portions 628 r, 630 r,and 636 r. Although the positioning section 96 r may be located in anyone of many different orientations relative to the patient's Adam'sapple 34 r, the position section 96 r is illustrated in FIG. 28 with theend portions 628 r and 630 r disposed on laterally opposite sides of thepatient's Adam's apple 34 r. The end portion 636 r is disposed adjacentto the lower end portion of the patient's Adam's apple 34 r. If desired,the orientation of the positioning section 96 r could be rotated by 180degrees from the orientation illustrated in FIG. 28. If this was done,the end portion 636 r on the positioning finger 634 r would be disposedadjacent to the upper portion of the patient's Adam's apple 34 r. It isbelieved that it will probably be preferred to align the pivotconnection 652 with the center of the patient's Adam's apple 34 r.However, if desired, the pivot connection 652 could be offset from thecenter of the patient's Adam's apple 34.

In the embodiments of the invention illustrated in FIGS. 25-28, thepositioning sections 96 m and 96 r have been illustrated as having threepositioning fingers. However, it is contemplated that the positioningsections could have either a greater number of positioning fingers or alesser number of positioning fingers if desired. For example, the centerpositioning finger 634 of the embodiment of the invention illustrated inFIGS. 25 and 26 could be omitted. If this was done, the positioningfinger 622 would be positioned on one side of the patient's Adam's apple34 m and the positioning finger 624 would be positioned on the laterallyopposite side of the patient's Adam's apple, in the manner illustratedin FIG. 26, without engaging the central portion of the patient's Adam'sapple. Alternatively, the positioning section 96 m or 96 r could beprovided with four positioning fingers. If this was done, two of thepositioning fingers would be positioned in engagement with the neck ofthe patient adjacent to one side of the patient's Adam's apple and theother two positioning fingers would be positioned in engagement with thepatient's neck on a laterally opposite side of the patient's Adam'sapple.

Conclusion

An improved method and apparatus for use in tracheal intubination orother medical procedures may include a positioning apparatus 56, 256.When the positioning apparatus 56, 256 is used for trachealintubination, the positioning apparatus is located relative to apatient's trachea 28, 228 by engaging a portion of the patient's body,such as the Adam's apple 34, 234. A flexible guide rod 50, 250 may bemoved relative to the positioning apparatus until a leading end portion52, 252 of the guide rod has moved into the patient's trachea. Atracheal tube 38, 238 is slid along the guide rod into the patient'strachea.

During movement of the guide rod 50, 250 relative to the positioningapparatus 56, 256, the guide rod may be moved through either a tubularguide member 264 or a tracheal tube 38, 238 which extends through thepatient's mouth into the patient's pharynx. Before beginning to move theguide rod 50, 250, the distance which the guide rod is to be moved mayadvantageously determined. This may be done as a function of spacingbetween locations on the positioning apparatus 56, 256. If desired,indicia 124, 324 may be provided on the positioning apparatus 56, 256and cooperating indicia 142, 342-350 may be provided on the guide rod50, 250.

A magnet 260 may be utilized to attract a leading end portion 252 of theguide rod 250. The magnet 260 is disposed outside of the patient's bodyand may be positioned adjacent to an anterior side of the trachea.Magnetic attraction between the magnet 260 and the leading end portion252 of the guide rod deflects the guide rod. This steers the leading endportion of the guide rod 250 into the entrance to the patient's trachea.A magnet may be used to steer a member relative to a patient's bodytissue during performance of operations other than trachealintubination.

In order to locate the guide rod 50, 250 and/or tracheal tube 38, 238relative to the patient's trachea, an image of body tissue adjacent tothe leading end portion of the guide rod and/or tracheal tube may betransmitted to a location outside of the patient's body (FIGS. 12 and20). Movement of the guide rod 50, 250 and/or tracheal tube 38, 238 intothe patient's trachea is interrupted when the image transmitted from theleading end portion of the guide rod or tracheal tube indicates that theleading end portion of the guide rod or tracheal tube has been moved toa desired position relative to the patient's trachea.

It is believed that transmission of an image of body tissue adjacent tothe leading end portion of the tracheal tube 38, 238 may advantageouslybe performed when the tracheal tube is utilized without benefit of thepositioning apparatus 56, 256. However, the transmission of an image ofbody tissue adjacent to the leading end portion of the tracheal tube 38,238 may be performed when the positioning apparatus is used inassociation with the tracheal tube. Positioning of the guide rod 50, 250relative to the patient's trachea may also be facilitated by thetransmitting of images of body tissue adjacent to a leading end portionof the guide rod.

Detectors and emitters 424, 426 may be utilized to detect the positionof the leading end portion of the guide rod 50, 250 and/or the trachealtube 38, 238 relative to the patient's trachea. When this is done, anemitter 424, such as a magnet or a light source, may be connected with aleading end portion 52, 252 of the guide rod 50, 250 and/or the trachealtube 38, 238. One or more detectors 426 may be provided on the outsideof the patient's neck to detect the output from the emitter 424 when theguide rod 50, 250 and/or the tracheal tube 38, 238 are in a desiredposition relative to the patient's trachea. Alternatively, a detector426 may be connected with the leading end portion of a guide rod 50, 250and/or tracheal tube 38, 238 and one or more emitters 424 positionedrelative to the outside of the patient's neck. The detector 426 wouldprovide an output indicating when the guide rod 50, 250 and/or trachealtube 38, 238 is moved to a desired position relative to the patient'strachea.

During movement of the guide rod 50, 250 and/or tracheal tube 38, 238along the patient's respiratory system and into the patient's trachea,force may be applied against the leading end portion 52, 252 of theguide rod and/or tracheal tube to steer the leading end portion of theguide rod and/or tracheal tube. The application of force against theleading end portion 52, 252 of the guide rod 50, 250 and/or trachealtube 38, 238 may be accomplished by expanding an expandable element464-468 connected with the guide rod 50, 250 and/or the tracheal tube38, 238.

It should be understood that any one of the features of the presentinvention may be used separately or in combination with other featuresof the invention. It's believed that various combinations of thefeatures, other than those disclosed herein, may advantageously beutilized and will be apparent to those skilled in the art from thedescription contained herein. In addition, it should be understood thatfeatures of the present invention may be used for purposes other thantracheal intubination. From the above description of the invention,those skilled in the art will perceive improvements, changes andmodifications. Such improvements, changes and modifications within theskill of the art are intended to be covered by the appended claims.

1. A method for administering a medicant at a treatment site in a bodyof a patient, the method comprising: providing a medical deviceincluding a leading end portion insertable into the body of the patient;releasably attaching a medicant to the leading end portion of themedical device; inserting the leading end portion, including themedicant, into the body of the patient; moving the leading end portionof the medical device along an insertion path in the body of thepatient, including attracting the leading end portion of the medicaldevice with a magnetic field emanating from a location outside of thepatient's body; and releasing the medicant at the treatment site.
 2. Themethod of claim 1 further comprising: applying a force against atrailing end portion of the medical device to move the medical devicealong the insertion path; and steering the leading end portion of themedical device along the insertion path under the influence of themagnetic field emanating from a location outside of the body of thepatient body.
 3. The method of claim 1 further comprising moving themagnetic field relative to the body of the patient.
 4. The method ofclaim 1 further comprising adjusting the strength of the magnetic field.5. The method of claim 1 wherein the magnetic field is provided by apermanent magnet or an electromagnet.
 6. A medicant delivery system foradministering a medicant at a treatment site in a body of a patient, thesystem comprising: a medical device including a leading end portionconfigured and dimensioned for insertion into the body of the patient; amedicant releasably attachable to the leading end portion of the medicaldevice; and a magnet for directing the leading end portion of themedical device through the body of the patient to the treatment site. 7.The system of claim 6 wherein the magnet has sufficient strength toalter the direction of the leading end portion of the medical device. 8.The system of claim 6 wherein the leading end portion of the medicaldevice includes a holder for attachment of the medicant and the medicaldevice includes an actuator for operating the holder from a closedposition in which the medicant is attached to the leading end portion toan open position in which the medicant is released from the leading endportion.
 9. A method for administering a medicant at a treatment site ina body of a patient, said method comprising: locating a positioningapparatus relative to an external portion of the patient's body byengaging the patient's body with the positioning apparatus; releasablyattaching a medicant to a leading end portion of an elongated member;determining a position to which the leading end portion of the elongatedmember is to be moved relative to the positioning apparatus; moving theelongated member into the patient's body while the positioning apparatusis in engagement with the patient's body; interrupting movement of theelongated member into the patient's body when the leading end portion ofthe elongated member has moved to the previously determined positionrelative to the positioning apparatus; and releasing the medicant fromthe leading end portion of the elongated member while the leading endportion is in the previously determined position relative to thepatient's body.
 10. The method of claim 9 wherein the step of moving anelongated member into the patient's body includes moving at least aportion of the elongated member through a portion of the positioningapparatus which is aligned with an opening in the patient's body. 11.The method of claim 9 wherein said step of locating the positioningapparatus relative to a portion of the patient's body includes varyingthe spatial relationship between first and second portions of thepositioning apparatus, said step of determining a position to which theleading end portion of the elongated member is to be moved relative tothe patient's body includes determining the position as a function ofthe spatial relationship between the first and second portions of thepositioning apparatus after the positioning apparatus has been locatedrelative to the patient's body and when the positioning apparatus isdisposed in engagement with the patient's body.
 12. The method of claim9 further including the step of disengaging the positioning apparatusfrom the elongated member prior to performance of said step of releasingthe medicant, said step of disengaging the positioning apparatus fromthe elongated member is performed with a portion of the elongated memberin the patient's body.
 13. The method of claim 9 wherein said step ofengaging a portion of the patient's body with the positioning apparatusincludes engaging spaced apart locations on the patient's body with thepositioning apparatus.
 14. The method of claim 9 wherein said step ofmoving the elongated member into the patient's body comprisesmagnetically attracting the leading end portion of the elongated memberwith a magnet disposed outside of the patient's body.
 15. The method ofclaim 9 wherein said step of moving the elongated member into thepatient's body includes detecting when the leading end portion of theelongated member is in a position other than a desired position andapplying force against the leading end portion of the elongated memberto move the leading end portion of the elongated member toward thedesired position.
 16. The method of claim 9 further including the stepof transmitting an image from the leading end portion of the elongatedmember to a location outside of the patient to facilitate visualizationof tissue disposed in the patient's body adjacent to the leading endportion of the elongated member.
 17. The method of claim 9 furtherincluding the steps of providing a sensor assembly having an emitterportion which provides an output and a detector portion which respondsto the output from the emitter portion, moving one of the emitter anddetector portions of the sensor assembly into the patient's body withthe leading end portion of the elongated member as the elongated membermoves into the patient's body, positioning the other of the emitter anddetector portions of the sensor assembly adjacent to the portion of thepatient's body engaged by the positioning apparatus, and determiningwhen the leading end portion of the elongated member is in a desiredposition relative to the patient's body as a function of a response fromthe detector portion of the sensor assembly during movement of theelongated member into the patient's body.
 18. The method of claim 17wherein said step of moving one of the emitter and detector portions ofthe sensor assembly into the patient's body with the leading end portionof the elongated member includes moving the emitter portion of thesensor assembly into the patient's body with the leading end portion ofthe elongated member, and said step of positioning the other of theemitter and detector portions of the sensor assembly adjacent to theportion of the patient's body engaged by the positioning apparatusincludes positioning the detector portion of the sensor assemblyadjacent to the portion of the patient's body engaged by the positioningapparatus.
 19. The method of claim 18 wherein said step of moving theemitter portion of the sensor assembly into the patient's body with theleading end portion of the elongated member includes moving a magnetinto the patient's body with the leading end portion of the elongatedmember, and said step of positioning the detector portion of the sensorassembly adjacent to the portion of the patient's body engaged by thepositioning apparatus includes positioning a device which responds to amagnetic field adjacent to the portion of the patient's body engaged bythe positioning apparatus.
 20. The method of claim 17 wherein said stepof moving one of the emitter and detector portions of the sensorassembly into the patient's body with the leading end portion of theelongated member includes moving the detector portion of the sensorassembly into the patient's body with the leading end portion of theelongated member, and said step of positioning the other of the emitterand detector portions of the sensor assembly adjacent to the portion ofthe patient's body engaged by the positioning apparatus includespositioning the emitter portion of the sensor assembly adjacent to theportion of the patient's body engaged by the positioning apparatus. 21.The method of claim 20 wherein said step of moving the detector portionof the sensor assembly into the patient's body with the leading endportion of the elongated member includes moving a device which respondsto magnetic fields into the patient's body with the leading end portionof the elongated member, and said step of positioning the emitterportion of the sensor assembly adjacent to the portion of the patient'sbody includes positioning a magnet adjacent to the portion of thepatient's body.
 22. The method of claim 9 wherein said step of moving anelongated member into the patient's body includes moving a plurality ofexpandable elements into the patient's body with the elongated memberand expanding at least one of the plurality of expandable elements asthe leading end portion of the elongated member is moved relative to thepatient's body.
 23. The method of claim 9 wherein said step of movingthe elongated member into the patient's body includes steering theleading end portion of the elongated member by expanding an expandableelement connected with the leading end portion of the elongated member.